• Scottish Intercollegiate Guidelines Network (SIGN). Bipolar affective disorder. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2005 May. 41 p. (SIGN publication; no. 82). [182 references]

Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.

The grades of recommendations (A-D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Definitions and Diagnosis

Diagnostic Scales

D - A diagnosis of bipolar affective disorder should be made after clinical assessment according to Diagnostic and Statistical Manual (DSM) or International Classification of Diseases of the World Health Organisation (ICD) criteria

Acute Treatment

Recommendations for the Treatment of Acute Mania

A - Acute manic episodes should be treated with oral administration of an antipsychotic drug or semisodium valproate.

A - Lithium can be used if immediate control of overactive or dangerous behaviour is not needed or otherwise should be used in combination with an antipsychotic.

Recommendations for the Treatment of Acute Depression

B - An antidepressant in combination with an antimanic drug (lithium, semisodium valproate or an antipsychotic drug), or lamotrigine is recommended for the treatment of acute bipolar depression in patients with a history of mania.

Maintenance

Pharmacological Relapse Prevention

Lithium

A - Lithium is the treatment of choice for relapse prevention in bipolar affective illness.

A - Lithium should be prescribed at an appropriate dose with a daily dosing regimen.

A - The withdrawal of lithium should be gradual to minimise the risk of relapse.

Carbamazepine

A - Carbamazepine can be used as an alternative to lithium, particularly in patients with bipolar II, or when lithium is ineffective or unacceptable.

Lamotrigine

A - Lamotrigine can be used for prophylaxis in patients who have initially stabilised with lamotrigine, particularly if depressive relapse is a greater problem than manic relapse.

Recommendations on Psychosocial Interventions

B - Evidence based psychosocial interventions should be available to patients in addition to pharmacological maintenance treatment, especially if complete or continued remission cannot be achieved.

Reproductive Health Issues

Contraception

Combined Oral Contraception (COC)

D - The dose of the combined oral contraceptive should be adjusted accordingly when given with an enzyme-inducing drug

D - Women should be warned that the efficacy of the COC is reduced

D - Barrier methods of contraception should also be used for maximal contraceptive effect

Progesterone-Only Contraception

D - The progestogen-only oral contraceptive is not recommended for women taking enzyme-inducing drugs

D - Depot injections of progesterone may be used with enzyme-inducing drugs if given every 10 weeks

D - Progesterone implants are not suitable for women taking enzyme-inducing drugs

Drugs in Pregnancy

Anticonvulsant Drugs (ACDs)

C - All women on antiepileptic drugs as mood stabilisers should be prescribed a daily dose of 5 mg folic acid from preconception at least until the end of the first trimester.

D - Valproate should be avoided as a mood stabiliser in pregnancy.

Lithium

C - Women with severe bipolar disorder, who are maintained on lithium, can be continued on lithium during pregnancy if clinically indicated.

C - The serum levels of women who are maintained on lithium therapy during pregnancy should be carefully monitored. Detailed fetal ultrasound scanning should be offered.

Benzodiazepines

B - Benzodiazepines should be avoided in the first trimester of pregnancy

Drug Treatment and Lactation

Lithium

D - Mothers taking lithium should be encouraged to avoid breast feeding, particularly if the infant is not full-term and healthy. If a decision is made to proceed, close monitoring of the infant, including serum lithium levels, should be undertaken.

Other Psychotropic Medication

D - New prescriptions for benzodiazepines should be avoided in breastfeeding mothers.

Note: This recommendation does not cover drug dependence, where breast feeding may be beneficial if the infant has been exposed to benzodiazepines in utero.

Suicide Prevention

D - Acute and maintenance lithium treatment of patients with bipolar affective disorders should be optimised to make every effort to minimise the risk of suicide.

Definitions:

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias

1+: Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies; high quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g., case reports, case series)

4: Expert opinion

Grades of Recommendation

Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.

A: At least one meta-analysis, systematic review of RCTs, or RCT rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

• Scottish Intercollegiate Guidelines Network (SIGN). Bipolar affective disorder. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2005 May. 41 p. (SIGN publication; no. 82). [182 references]

Not applicable: The guideline was not adapted from another source.

2005 May

Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]

Scottish Executive Health Department

Not stated

Guideline Development Group: Professor Klaus Ebmeier (Chair), Professor of Psychiatry, University of Edinburgh; Dr Benjamin Baig (Secretary), Senior House Officer, Royal Edinburgh Hospital; Ms Ailsa Brown, Health Economist, Greater Glasgow Health Board; Dr Jonathan Cavanagh, Senior Lecturer in Psychiatry, Gartnavel Hospital, Glasgow; Dr Stella Clark, Acting Medical Director, Fife Primary Care NHS Trust; Professor Kate Davidson, Director of Glasgow Institute of Psychosocial Interventions, University of Glasgow; Ms Nadine Dougall, Research Fellow, University of Edinburgh; Mrs Karen Fraser, Principal Pharmacist - Mental Health, Ailsa Hospital, Ayr; Dr Kenneth Lawton, General Practitioner, Aberdeen; Ms Fiona Mitchell, Community Psychiatric Nurse, Westbank Clinic, Falkirk; Dr Anne Nightingale, Consultant Psychotherapist, Lansdowne Clinic, Glasgow; Mr Chris O'Sullivan, Lay representative, Edinburgh; Professor Mick Power, Clinical Psychology Course Director, University of Edinburgh; Professor Ian Reid, Professor of Psychiatry, Aberdeen University; Mr Duncan Service, Senior Information Officer, SIGN Executive; Mrs Marion Shawcross, Social Work Officer, The Mental Welfare Commission for Scotland, Edinburgh; Ms Ailsa Stein, Programme Manager, SIGN Executive; Ms Joanne Topalian, Programme Manager, SIGN Executive; Dr Alan Wade, General Practitioner, Glasgow; Mr Laurence Wilson Lay representative, Glasgow

Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive.

None available

This summary was completed by ECRI on July 15, 2005. The information was verified by the guideline developer on July 26, 2005. This summary was updated by ECRI on November 16, 2006, following the FDA advisory on Lamictal (lamotrigine). This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on January 10, 2008, following the U.S. Food and Drug Administration advisory on Carbamazepine.