Patients with bipolar disorder in a depressive episode are randomised to receive escitalopram or placebo for eight weeks. Responders to escitalopram are re-randomised to placebo or escitalopram for 32 weeks' maintenance treatment. Placebo-responders continue placebo for the whole maintenance phase.
Conditions
Interventions
Trade Name: Cipralex
Product Name: escitalopram
Pharmaceutical Form: Tablet
INN or Proposed INN: escitalopram
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Ph
Sponsors
Nordfjord Psychiatric Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? bipolar disorder type I or II in major depressive episode according to DSM-IV (as diagnosed by the Mini International Neuropsychiatric Interview (MINI)) ? MADRS score of at least 20 points ? age 18 - 70 ? unchanged dose of mood stabilisers for at least six weeks prior to inclusion ? voluntary, informed and written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? non-affective psychotic symptoms at screening or baseline ? pregnancy or breast-feeding ? fertile women without appropriate contraception ? substance abuse or dependence during the last three months prior to baseline ? mental retardation and organic brain disorders ? suicide risk that mandates specific measures ? novel (within three months) or unstable medical conditions ? clinically significant abnormal results on medical examination or blood samples ? exposure to escitalopram during the last three months ? allergic reactions to citalopram or escitalopram ? anorexia nervosa with body mass index below 18 ? formal psychotherapy started within six weeks of baseline ? electroconvulsive therapy (ECT) during the current episode of depression ? patients who are unlikely to be reliable and compliant with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study has two principal aims: 1)To compare the efficacy and the risk of mood switching of escitalopram and placebo in the acute phase treatment of bipolar depression in patients already taking mood stabilisers. 2) to compare the efficacy of escitalopram and placebo in the continuation phase therapy for bipolar depression using a placebo-controlled discontinuation design. ;Secondary Objective: The study will compare the occurrence of syndromal and subsyndromal relapses, mixed states, mania, hypomania, and rapid cycling in the seven months following response to acute phase treatment.;Primary end point(s): For the acute phase, response and remission rates as assessed by the MADRS are the primary outcome measures. CGI-Improvement and change on the IDS-SR are secondary outcome measures. In the continuation study secondary primary outcome measures are emergence of major depressive episodes and mania/hypomania, while time spent at different depressive symptom levels as assessed by the DSM-IV diagnostic criteria are secondary outcome measures. | — |
Countries
Norway
Outcome results
None listed