Status:
TERMINATED
Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment
Lead Sponsor:
Nordfjord Psychiatric Centre
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Funding: An investigator-initiated trial funded by H. Lundbeck AS. Study design: Prospective, randomised, placebo-controlled parallel-group multicenter study. Aim: To investigate efficacy and side e...
Detailed Description
Aims The study has two main 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 takin...
Eligibility Criteria
Inclusion
- Patients with bipolar disorder in major depressive episode according to DSM-IV
- MADRS score of at least 20 points at screening and baseline
- 18-70 years of age
- Unchanged dose of mood stabilising medication for at least six weeks prior to inclusion
- Voluntary, informed and written consent
Exclusion
- Non-affective psychotic symptoms at screening
- Pregnancy or breast-feeding
- Fertile women without appropriate contraception (the pill, IUD, or contraceptive injection)
- Substance 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 screening
- Electroconvulsive therapy (ECT) during the current episode of depression
- Patients who are unlikely to be reliable and compliant with study procedures
- Patients who are not fluent in Norwegian
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00464191
Start Date
April 1 2006
End Date
March 1 2009
Last Update
September 21 2009
Active Locations (1)
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1
Nordfjord Psychiatric Centre
Nordfjordeid, Norway, 6770