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Bipolar formulary guidance

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Contents

  1. Introduction
  2. Pharmacological treatment of bipolar disorder
  3. Monitoring
  4. Communication in primary care
  5. References
  6. Appendices

1 Introduction

These guidelines are intended for routine use. However, there will be instances where they are not suitable for the patient you are managing, where more bespoke treatment will be necessary. In such instances the rationale for prescribing away from formulary must be recorded.

Bipolar affective disorder (BPAD) is a chronic, recurrent condition associated with high levels of suffering, occupational dysfunction, impaired social life and relationships, as well as increased morbidity and mortality.

Bipolar disorder is often co-morbid with a range of other mental disorders (for example substance misuse, personality disorders and attention deficit hyperactivity disorder (ADHD)) and this has significant implications for both the course of the disorder and its treatment.

The treatment of BPAD is based primarily on psychotropic medication to reduce the severity of symptoms, stabilise mood and prevent relapse. The treatments are determined by the phase of illness and subtype of disorder.

Individual variation in response to medication will often determine the choice of drug, as will side effects, interactions and cautions associated, the need for rapid onset, child bearing potential, previous history and individual preferences.

A range of psychological and psychosocial interventions can also be used.

See table 4B on Valproic acid for guidance on the PREVENT programme.

2 Pharmacological treatment of bipolar disorder

2.1 Bipolar mania or hypomania

  • Consider withdrawing antidepressant at onset of manic episode, abruptly or gradually, as appropriate due to the propensity to exacerbate symptoms.
  • Initiate oral antipsychotic, if the patient is not already on one or a mood stabiliser offer haloperidol, olanzapine, quetiapine or risperidone.
  • If this is ineffective or not tolerated, offer an alternative antipsychotic.
  • If this is still ineffective consider adding Lithium.
  • If Lithium is not suitable or is ineffective, consider adding valproic acid (see Medicines and Healthcare products Regulatory Agency (MHRA) guidance for use in women of child bearing age).
  • Short term use of benzodiazepines may be considered in addition to manage agitation.
  • Aripiprazole is recommended as an option for treating moderate to severe manic episodes in adolescents with bipolar I disorder, within its marketing authorisation (that is, up to 12 weeks of treatment for moderate to severe manic episodes in bipolar I disorder in adolescents aged 13 and older) (NICE TA292).

2.2 Acute manic episode while already taking antimanic medication

  • If a patient already taking an antipsychotic experiences a manic episode, the dose should be checked, and increased if necessary. If there is no improvement, Lithium or valproic acid should be considered in addition.
  • If a patient who is already taking lithium experiences a manic episode, plasma lithium levels should be checked. If the response is inadequate, augmenting with an antipsychotic could be considered.
  • If a patient is already taking valproic acid and experiences a manic episode, the dose should be increased until symptoms start to improve depending on side effects, if there is no improvement consider augmenting with an antipsychotic.
  • If a patient who is already taking lithium or valproic acid presents with severe mania, consider increasing the dose and adding an antipsychotic.
  • If a patient on carbamazepine presents with mania, the dose should not be routinely increased, an antipsychotic should be considered, however be aware of interactions.

2.3 Bipolar depression

  • In patients are treatment naive National Institute for Health and Care Excellence (NICE) recommends offering Fluoxetine combined with Olanzapine or Quetiapine as monotherapy.
  • If fluoxetine is not appropriate consider using the depression guidelines for choosing an alternative antidepressant.
  • If the person prefers, consider olanzapine or Lamotrigine as monotherapy.
  • If the patient is already on a mood stabiliser, maximise that first and then treat as above.

2.4 Bipolar disorder, long term treatment

  • First line offer lithium.
  • If ineffective, consider adding valproic acid.
  • If poorly tolerated, or issues with monitoring consider valproic acid or olanzapine, or if it has been effective in acute treatment of depression or mania consider quetiapine
  • If stopping long term treatment discuss with the patient how to recognise the signs of relapse and what to do.
  • Continue monitoring symptoms, mood and mental state for two years after medication has been stopped entirely, this can be done in primary care

2.5 Bipolar disorder, rapid cycling

NICE guidance recommends that patient s that have 4 or more acute episodes in a year are classified as having rapid-cycling bipolar disorder.

There is limited evidence on treatments on rapid cycling. A key element is to avoid treatment that may induce switching to a manic state, in particular with antidepressants, where there is a 12% to 20% chance of switching.

Treatment should be as for manic and depressive episode, but in addition:

  • review the patient’s previous treatments for bipolar disorder, and consider a further trial of agents that were not given an adequate trial, or where there was poor compliance
  • optimize long-term treatment rather than focussing on treating individual episodes and symptoms
  • try a psycho-educational approach and encourage patient s to keep a regular mood diary to monitor progress and changes in severity and frequency of symptoms
  • if on an antidepressant, withdraw this due to risk of cycling
  • identify and manage possible precipitants, for example, alcohol, thyroid dysfunction, and external stressors
  • optimise mood stabiliser treatment
  • each trial of medication should usually last at least 6 months
  • for many, combination treatment may be required
  • consider prescribing a combination of Lithium and Valproic acid
  • consider other (adjunct) antipsychotic treatment options (for example, in alphabetical order):
    • aripiprazole (15mg to 30mg per day)
    • carbamazepine
    • clozapine (Usual doses; off-label use)
    • lamotrigine (up to 225mg per day)
    • olanzapine (usual doses)
    • quetiapine (300mg to 600mg per day) currently, may have the best supporting data
    • risperidone (up to 6mg per day)

Choice of drug is determined by patient factors.

2.6 Bipolar disorder, mixed affective state

A small proportion of patients will present with a mixed affective state, where the patient will present with a combination of manic or hypomanic and depressive symptoms, along with commonly a marked dysphoria. These patients are at particular risk of switching when given antidepressants.

  • Treat as hypomania or mania.
  • Stop or withdraw antidepressants.
  • Maximise mood stabilisers.

3 Monitoring

During review of treatment, patient s should be specifically questioned about the efficacy of the medication, functioning, concordance, and adverse effects. Side effects should be documented in the notes, and where appropriate reported via the yellow card scheme. Doses and decision to continue should be reviewed on an ongoing basis.

Bipolar disorder (BPAD) is associated with poor physical health and drug treatments can add to this. Patients are at an increased risk of metabolic syndrome. NICE recommends monitoring physical health at baseline and at least annually as follows:

  • lipid profile
  • glucose or HbA1c
  • weight and height
  • blood pressure
  • prolactin
  • thyroid function tests
  • liver function tests
  • full blood count
  • smoking and alcohol status
  • electrocardiogram (ECG), where cardiac history suggests or summary of product characteristics (SPC) requirement
  • urea and electrolytes (U&E) or renal function (estimated glomerular filtration rate (eGFR))

See table 5 for more guidance.

4 Communication in primary care

Different areas of the trust have slightly different shared care arrangements with GPs, however in principle, with the GP’s agreement once the patient is on a stable dose then primary care can take over prescribing under shared care. Good communication is key, and clear lines of responsibility must be agreed between primary and secondary care (in Doncaster a pro forma is in place to support these arrangements).

5 References

6 Appendices

6.1 Table 1 Acute treatment of mania or hypomania

6.1.1 First line

First line Relative costs Notes
Oral

antipsychotics

Risperidone

Haloperidol

Olanzapine

Quetiapine XL

  

 

£

£

£

£ to ££

 Evidence of advantage in acute mania. Consider atypical antipsychotics (because of their generally more favourable short-term side effect profile) if manic symptoms are severe or there is marked behavioural disturbance. Before prescribing consider side effect profile and individual risk factors, for example, diabetes, weight and cardiovascular risk, adherence and previous response.

Risk of weight gain, hyperglycaemia, dyslipidaemia, hypercholesterolaemia, hyperprolactinaemia.

Monitor weight, glucose and lipids and prolactin. If stopping, discontinue gradually.
Benzodiazepines

Lorazepam

Clonazepam

  

£

£

 Use PRN for as short time as possible; Consider if severe anxiety and agitation present of if sleep deprived. Benzodiazepines can rapidly diminish overactivity.

Risk of disinhibited behaviour, tolerance, withdrawal symptoms and dependence.

Also increased risk of sedation, falls and ataxia.

6.1.2 Second line

Second line Relative costs Notes
Lithium £ For less severe symptoms and control of overactive behaviour not immediately required. Slower onset of action approximately 7 days. Consider if previous good response and compliant with monitoring (see notes on lithium, above)
Valproic Acid, see Valproate safety measures (opens in new window)

 

 ££ Has rapid antimanic effect. Consider if previous good response; for monitoring, see notes above.

Do not prescribe routinely for women of child-bearing potential, see MHRA guidance.
Alternative antipsychotic £ to £££ Consider an alternative antipsychotic not tried, for example, haloperidol or zuclopentixol.
Carbamazepine £ No longer in NICE guidance, however may be considered if other recommended options are ineffective or not tolerated.

6.1.3 Not recommended

Not recommended Relative costs Notes
Antidepressants

Lamotrigine

Topiramate

Gabapentin

 £ to £££ Antidepressants should be abruptly discontinued or dose tapered and discontinued, as appropriate.

There is inadequate supporting evidence for these anticonvulsants in acute mania.

6.2 Table 2 Acute depressive episodes

6.2.1 First line

First line Relative costs Notes
Olanzapine and Fluoxetine £ In naive patients
Quetiapine £ to ££ Consider if early effect is desirable. Appears to not be associated with a switch to mania and add an antimanic agent if not on maintenance treatment and bipolar I.
Lamotrigine £ Does not induce switching or rapid cycling. Care with dose, very slow dose titration required.

NICE does not recommend Lamotrigine as a single first line agent in bipolar I disorder
Increased risk of a rash is associated with rapid dose titration or concurrent use of valproic acid and add an antimanic agent if not on maintenance treatment and Bipolar I disorder.

6.2.2 Second line

Second line Relative costs Notes
Antidepressants £ to ££
  • Always prescribe a mood stabiliser in combination.
  • Add a selective serotonin reuptake inhibitor (SSRI) in moderate depression Avoid tricyclics or MAOIs.
  • Care, when prescribing SSRIs concurrently with non-steroidal anti-inflammatory drugs (NSAIDS) due to risk of bleeding.
  • Serotonin syndrome can occur with serotonergic drugs, with co-prescribing of SSRIs and lithium. it can present as:
    • agitation
    • confusion
    • tremor
    • hyperreflexia
    • myoclonus
    • hypermania
  • NICE recommends venlafaxine or mirtazapine as alternative second line antidepressant options for patients who fail to respond to initial treatment.

Consider stopping the antidepressant if in remission from depressive symptoms (or symptoms have been significantly less severe for 8 weeks)
Valproic Acid and Lithium £ When depressive symptoms are less severe, lithium or valproic acid may be considered. Slower onset, takes 6 to 8 weeks; If already on lithium or valproic acid as a prophylactic agent, optimise dose.
Olanzapine £ If patient prefers monotherapy.

6.2.3 Third line

Third line Relative costs Notes
ECT  £££ Consultant initiation only. Consider for high suicide risk and severe depression.

6.2.4 Not recommended

Not recommended Relative costs Notes
Antidepressant monotherapy £ to ££ Antidepressant monotherapy, due to risk of switching to mania especially in bipolar I disorder.

Tricyclic antidepressants are more likely to result in switching to mania.

6.3 Table 3 Bipolar affective disorder, long term maintenance therapy (relapse prevention)

6.3.1 First line

First line Relative costs Notes
Lithium £ Lithium monotherapy is probably effective against both manic and depressive relapse, although more effective in preventing mania.

Lithium is associated with a reduced suicide risk in individuals with bipolar.

Prescribe by generic name and specify brand.

Different preparations should not be assumed to be bioequivalent; When prescribing liquid preparations, clearly specify strength and dose.
Valproic Acid ££ Valproic acid probably prevents both manic and depressive relapse (but see MHRA guidance).

Interactions, valproic acid can increase levels of carbamazepine and lamotrigine.
Olanzapine £ Consider risks, response and preference. Olanzapine prevents manic and depressive relapse.

Consider Quetiapine if the patient has responded well to it during an episode of bipolar depression or mania.

6.3.2 Second line

Second line Relative costs Notes
Combination therapy £ to £££ Use combinations of prophylactic agents if frequent relapses or significant functional impairment.
Lamotrigine £ Consider if bipolar II disorder; Prevents depressive more than manic relapse. Can be used as prophylaxis in patient s initially stabilised with lamotrigine or for recurrent depressive episodes.
Carbamazepine £ Carbamazepine is less effective than lithium but can be used if lithium is ineffective.

Hepatic enzyme inducer (risk of significant interactions) with other medications.

Reduces effectiveness of oral contraceptives. The dose of contraceptive should be adjusted, and barrier methods used; Teratogenic risk of neural tube defects, craniofacial abnormalities.

6.3.3 Third line

Third line Relative costs Notes
Clozapine ££ Consider clozapine for treatment-refractory symptoms (off-label use).

6.3.4 Other

Other Relative costs Notes
Benzodiazepines £ Short-term use when an acute stressor (such as anxiety or lack of sleep) is present.
Antidepressants £ to ££ Consider long-term treatment with SSRI and mood stabiliser for chronic recurrent depression.

6.4 Table 4 prescribing information for specific drugs

6.4.1 Table 4A Lithium

Drug, licenced indications Dose Contraindications and cautions Side effect and interactions
Lithium (Priadel or Camcolit) formulation

  • Tablets m/r, lithium carbonate 200mg and 400mg Tablets 250mg ir
  • Liquid, sugar-free, lithium citrate 520mg/5ml (5ml dose is equivalent to approximately 200mg lithium carbonate)

Lithium (Priadel or Camcolit) licenced indications

  • Prophylaxis of bipolar affective disorder
  • Treatment of acute manic or hypomanic episodes
  • Dose range for treatment and prophylaxis is 400mg to 1200mg daily as a single dose or in 2 divided doses (if elderly or less than 50kg, 400mg daily).
  • Dose adjusted to achieve lithium levels in the range of 0.4mmol/l to 1mmol/l.
  • Sample taken at least 12 hours after the last dose.
  • Levels should not exceed 1.5mmol/l.
  • Optimal serum lithium levels may vary for each patient.
  • Additional serum-lithium levels should be made if significant intercurrent disease or change in sodium or fluid intake.
  • Preparations vary widely in bioavailability; changing the preparation requires the same precautions as initiating treatment.
  • Discontinue gradually.
 Contraindications

  • Hypersensitivity to lithium or excipients
  • Cardiac disease
  • Cardiac insufficiency
  • Severe renal impairment
  • Untreated hypothyroidism
  • Breast-feeding
  • Hyponatremia, including due to dehydration or low sodium diets
  • Addison’s disease
  • Brugada syndrome or family history of Brugada syndrome

Cautions

  • Renal and thyroid dysfunction,
  • Electrolyte imbalance or diuretics
  • Cardiac problems
  • Psoriasis
  • Seizures
  • QT interval prolongation
  • Elderly people
  • Drug interactions
  • Low sodium diet
  • Dehydration, diarrhoea, vomiting

Pregnancy

Avoid in first trimester of pregnancy if possible.

Dose adjustments in second and third trimesters with close monitoring of serum levels (neonatal toxicity).

 Side effects

  • Lithium has a narrow therapeutic index
  • Side effects are related to serum levels, as follows:
    • mild gastrointestinal side effects such as nausea, abdominal discomfort and taste disorder
    • tremor, especially fine hand tremors
    • peripheral oedema and weight gain
    • hyperglycaemia
    • leucocytosis
    • confusion
    • reduction in thyroid and renal function
    • polydipsia and, or polyuria
    • sexual dysfunction
  • High serum-lithium levels (usually greater than 1.5mmol/l) can cause toxic effects including:
    • restlessness
    • apathy
    • nausea
    • coarse tremor
    • vomiting
    • diarrhoea
    • drowsiness
    • blurred vision
    • ataxia
    • dysarthria
    • myalgia and arthralgia
  • Lithium should be stopped. Higher levels can lead to confusion, hyperreflexia, renal failure, convulsions, coma and death.
  • Long-term adverse effects may include thyroid function disturbances such as euthyroid goitre and, or hypothyroidism and thyrotoxicosis

Key interactions

NSAIDs; Diuretics, for example, thiazides, ACE Inhibitors; Angiotensin II antagonists, calcium channel blockers, additive effect with psychotropic drugs

6.4.2 Table 4B Valproic acid

Drug, licenced indications Dose Contraindications and
cautions		 Side effect and
interactions
Valproic acid

  • Depakote: tablets 250mg; 500mg (other valproic acid preparations are also used off label (reserved for when compliance issues around Depakote)

Licenced indications

  • Treatment of manic episodes associated with bipolar disorder. Prophylaxis of bipolar disorder
  • Initial dose, 750 mg daily in 2 to 3 divided doses, increased according to response
  • Maintenance dose, 1g to 2g daily doses greater than 45mg/kg daily require careful monitoring
  • see above for monitoring schedule
 Contraindications

Cautions

  • Women of child-bearing potential
  • Monitor liver function before therapy and during first 6 months especially in those most at risk
  • Measure full blood count and ensure no undue potential for bleeding before starting and before surgery
  • Systemic lupus erythematosus
  • False-positive urine tests for ketones
  • Avoid abrupt withdrawal
  • Consider vitamin D supplementation in patients that are immobilised for long periods or who have inadequate sun exposure or dietary intake of calcium
  • See Valproate safety measures (opens in new window)
 Side effects

  • Gastrointestinal disturbances, particularly at the start of therapy. Increased appetite, and weight gain is common
  • Less common adverse effects include oedema, headache, reversible prolongation of bleeding time, and thrombocytopenia. Leucopenia and bone marrow depression have been reported.
  • Tremor and ataxia have also been reported usually when therapy is started.
  • Transient hair loss.
  • Occasionally rashes
  • Rare but serious
    side effect are liver damage and pancreatitis

Interactions

  • Caution is recommended when giving valproic acid with other drugs liable to interfere with blood coagulation, such as aspirin or warfarin
  • Use with other hepatotoxic drugs should be avoided
  • Use of highly protein bound drugs with valproic acid may increase free valproic acid plasma concentrations
  • Care with dosing when used with lamotrigine, potential for additive effects when used with other psychotropic drugs
6.4.2.1 Valproic acid prevent programme

Valproic acid is an effective treatment for epilepsy and bipolar disorder. In girls and women of childbearing potential valproic acid must be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. Valproic acid should not be used in girls and women of childbearing potential unless other treatments are ineffective or not tolerated. Valproic acid may be initiated in girls and women of childbearing potential only if the conditions of prevent, the valproic acid pregnancy prevention programme (outlined below) are fulfilled.

6.4.2.2 Specialists
  • Discuss the risks with the patient (or parent/caregiver/responsible person).
  • Exclude pregnancy in women of childbearing potential (by serum pregnancy test) before the first prescription is issued.
  • Arrange for highly effective contraception for women of childbearing potential before the first prescription is issued.
  • Complete the annual risk acknowledgment form with patient (or parent, caregiver, or responsible person); give them a copy and send a copy to the GP.
  • See the patient urgently (within days) if referred back in case of unplanned pregnancy or if she wants to plan a pregnancy.
  • Provide a copy of the patient guide to the patient (or parent, caregiver, or responsible person).
6.4.2.3 General practitioners
  • Ensure continuous use of highly effective contraception in all women of childbearing potential (consider the need for pregnancy testing if not a highly effective method).
  • Check that all patients have an up to date, signed, annual acknowledgment of Risk Form each time a repeat prescription is issued.
  • Ensure the patient is referred back to the specialist for review, annually.
  • Refer back to the specialist urgently (within days) in case of unplanned pregnancy or where a patient wants to plan a pregnancy.
  • See Valproate safety measures (opens in new window)

CHM and MHRA are reviewing this guidance at time of writing, and may update it covering all patients under 55 including men.

6.4.3 Table 4C Carbamazepine

Drug, licenced indications Dose Contraindications and
cautions		 Side effect and
interactions
Carbamazepine

  • Tablets 100mg, 200mg and 400mg
  • Prolonged release 200mg and 400mg tablets
  • Liquid 100mg/5ml

Licensed indications

  • Prophylaxis of bipolar disorder unresponsive to lithium
  • Initial dose, 400mg daily in divided doses
  • Maintenance dose, 400mg to 600mg daily; maximum 1.6g daily
 Contraindications

  • Atrioventricular (AV) conduction abnormalities (unless paced); history of bone-marrow depression; acute porphyria; known hypersensitivity to carbamazepine or structurally related drugs (for example, tricyclic antidepressants)
  • Not recommended in combination with monoamine oxidase inhibitors (MAOIs)

Cautions

  • Cardiac disease
  • History of haematological reactions to other drugs
  • Susceptibility to angle-closure glaucoma
  • Liver dysfunction or acute liver disease
  • Manufacturer recommends blood counts and hepatic and renal function tests, Plasma monitoring is required to
    exclude toxicity
 Side effects

  • Common side effects include:
    • dizziness and ataxia
    • gastrointestinal disturbances, for example, nausea and vomiting
    • blurred vision
    • hypertension
    • hypotension
    • mild skin reactions
    • transient leucopenia
  • Serious dermatologic side effects include generalised erythematous rashes Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Blood disorders reported include:
    • eosinophilia
    • leucopenia
    • thrombocytopenia
    • haemolytic anaemia
    • anaemia
  • Also reported are hepatitis, jaundice, pancreatitis
  • Abnormalities of kidney function and cardiac conduction disorders. Congestive heart failure. Hyponatraemia have occurred
  • Exacerbation of seizures
  • congenital malformations have been reported in infants born to women given carbamazepine during pregnancy

Interactions

  • Carbamazepine is a hepatic enzyme inducer, and induces its own metabolism as well as that of other drugs including antibacterials (for example, doxycycline), anticoagulants, and sex hormones (notably oral contraceptives) reducing therapeutic effect
  • Drugs that induce CYP3A4 may increase the metabolism of carbamazepine
  • May interact with MAOIs, other antiepileptics or mood stabilisers

6.4.4 Table 4D Lamotrigine

Drug, licenced indications Dose Contraindications and
cautions		 Side effect and
interactions
Lamotrigine

  • (non-proprietary) or Lamictal

Licenced indication

  • adults aged 18 years and above
  • prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes
 Monotherapy or adjunctive therapy of bipolar disorder (without enzyme inducing drugs) without valproic acid

  • Initially 25mg once daily for 14 days
  • Then 50mg daily in 1 to 2 divided doses for further 14 days
  • Then 100mg daily in 1 to 2 divided doses for further 7 days
  • Usual maintenance, 200mg daily in 1 to 2 divided doses; maximum 400mg daily

Adjunctive therapy of bipolar disorder with valproic acid

  • Initially 25mg on alternate days for 14 days
  • Then 25mg once daily for further 14 days
  • Then 50mg daily in 1 to 2 divided doses for further 7 days
  • Usual maintenance, 100mg daily in 1 to 2 divided doses; maximum 200mg daily

Adjunctive therapy of bipolar disorder (with enzyme inducing drugs) without valproic acid

  • Initially 50mg once daily for 14 days
  • Then 50mg twice daily for further 14 days
  • Then 100mg twice daily for further 7 days
  • Then 150mg twice daily for further 7 days
  • Usual maintenance, 200mg twice daily dose adjustments may be required if other drugs are added to or withdrawn from their treatment regiment
 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Cautions

  • Skin reactions, monitor and withdrawal if rash, fever, or other signs of hypersensitivity syndrome develop
  • Increases clearance of hormonal contraceptive
  • Parkinson’s disease, risk of exacerbation
  • Blood disorders
  • Renal or hepatic impairment
  • Skin rash
  • Nausea
  • Vomiting
  • Diarrhoea
  • Dry mouth
  • Aggression
  • Irritability
  • Headache
  • Somnolence
  • Dizziness
  • Tremor
  • Insomnia
  • Agitation
  • Arthralgia
  • Tiredness
  • Pain
  • Back pain
  • Nystagmus
  • Diplopia
  • Blurred
    vision
  • Hypersensitivity syndrome
  • Blood disorders

6.5 Table 5 Physical health monitoring for patients with bipolar disorder

Adapted from NICE CG30 for Lithium and Antipsychotics see tables 6 and 7.

Parameter Initial health
check		 Annual check
up		 Valproic
acid		 Carbamazepine
Thyroid function Yes Yes
Liver function Yes At start and at 6 months At start and at 6 months
Renal function Yes Urea and electrolytes
every 6 months
Full blood
count		 Yes At start and 6 months At start and at 6 months
Blood (plasma) glucose Yes Yes
Lipid profile Yes Over 40s only
Blood pressure Yes Yes
Prolactin Yes
Electrocardiogram (ECG) If indicated by history or clinical picture
Weight and height Yes Yes At start and at 6 months If patient gains weight rapidly At start and at 6 months If patient gains weight rapidly
Drug screening and chest X-ray If suggested by history or clinical picture
Electroencephalogram (EEG), magnetic resonance imaging (MRI), computed tomography (CT) scans If organic aetiology or comorbidity is suspected
Smoking or alcohol Yes Yes
Serum levels of drug Only if there is evidence of ineffectiveness, poor adherence or toxicity Every 6 months

6.6 Table 6 Monitoring of patients on Lithium

Test Baseline Weekly till stable 3 monthly 6 monthly Annually
Weight, height and body mass index (BMI) Yes Yes
Alcohol and smoking Yes Yes
Electrocardiogram (ECG) If indicated by cardiac history or other risk factors Yes if indicated
U&E’s and eGFR Yes Yes if CKD 3a or worse Yes if stable and no concerns
Calcium Yes Yes Yes
Thyroid function tests (TFT’s) Yes Yes
Urine albumin to creatinine ratio (ACR) If eGFR stage 3a or worse Yes
Lithium levels Yes Yes Yes (for first year)
and lithium levels (after the first year) or every 3 months for people in any of the following groups:

  • older people, older than 65
  • taking drugs that interact with lithium
  • who are at risk of impaired renal or thyroid function, raised calcium levels or other complications
  • who have poor symptom control
  • poor adherence
  • last plasma lithium level was 0.8mmol/l or higher
 Yes (after first year if not in at risk group, see previous box)

6.7 Table 7 Monitoring of antipsychotics

Clozapine,
clozapine monitoring
covered separately		 Baseline At one
month		 At three
months		 At 6
months		 At 12 months
then annually
(general information 1)
Blood pressure (legend 2 and 8) NICE guidance NICE guidance
Pulse (legend 2 and 8) NICE guidance NICE guidance
Bodyweight or BMI (legend 3) NICE guidance NICE guidance NICE guidance NICE guidance
HbA1c (legend 4) NICE guidance Olanzapine (legend 4) NICE guidance NICE guidance
Blood lipids NICE guidance NICE guidance NICE guidance
Renal function (U&E, eGFR) NICE guidance NICE guidance
Full blood count (FBC) NICE guidance NICE guidance
Liver function test (LFT) NICE guidance NICE guidance
TFT (Quetiapine only) Maudsley guidance Maudsley guidance
Prolactin (legend 5) NICE guidance NICE guidance NICE guidance
Creatine phosphokinase (CPK) (legend 6) Maudsley guidance
Electrocardiogram (ECG) NICE guidance NICE guidance
Side-effects (GASS or like) (legend 2) NICE guidance NICE guidance
Adherence to medication (legend 2) NICE guidance
Overall physical health (legend 2) NICE guidance NICE guidance
Smoking status NICE guidance NICE guidance
Alcohol or drug status NICE guidance NICE guidance
Movement disorders (legend 2 and 7) NICE guidance NICE guidance
Physical activity (legend 7) NICE guidance NICE guidance
Nutritional status (legend 7) NICE guidance NICE guidance

6.7.1 Legend

  1. Diagnosis discussed with patient and appropriate information sheet given as necessary.
  2. The choice of antipsychotic considered appropriate for the patient, has been discussed with the patient and or advocate. This includes advanced plans or directives if available and likely side effects of the specific drugs (see formulary).
  3. Written information regarding specific antipsychotic(s) given to patient or carer (opens in new window).
  4. Baseline physical health checks are carried out, recorded and discussed with the patient or carer to specifically include taking cardiac, smoking and alcohol histories.
  5. Review date to assess efficacy and tolerability made in the diary, and patients treatment plan.
  6. This guidance is based on results being within normal limits. Tests may need to be repeated more often due to individual clinical indicators.
  7. Additional detail is available in the trust formulary and individual drug summary of product characteristics (SPCs).

Monitoring (not necessarily prescribing). The secondary care team should maintain responsibility for monitoring service users’ physical health and the effects of antipsychotic medication for at least the first 12 months or until the person’s condition has stabilised, whichever is longer. Thereafter, the responsibility for this monitoring may be transferred to primary care under shared care arrangements.

6.7.2 Use of electrocardiogram (ECG) in monitoring for antipsychotics

Electrocardiogram (ECG) mandatory for haloperidol, pimozide and sertindole. Not required for:

  • antipsychotics with no or low to moderate effect on QT interval
  • where there are no other risks for arrhythmia
6.7.2.1 Inpatients
  • at baseline for all patients on admission
  • at dose change and when reaching target dose
  • prior to discharge if there has been a change in treatment
6.7.2.2 Community patients
  • patients with a personal history of cardiovascular disease
  • where there is an identified cardiac risk factors.
  • where specified in the drug’s summary of product characteristics
  • if ECG indicated, repeat at dose change and ideally annually

Page last reviewed: January 15, 2025
Next review due: January 15, 2026

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