Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment

NCT00464191 | Terminated Phase 4

• 3 other identifiers: EudraCT 2005-004357-94Lundbeck 10968NPS 2005-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 effects (especially mood switches) of escitalopram,a selective serotonin reuptake inhibitor, in the acute and maintenance treatment of bipolar depression. Hypotheses:

1. 1.Escitalopram, given in addition to mood stabilising medications, is significantly more efficacious, measured by response and remission rates than placebo in bipolar depression (the acute phase study).
2. 2.Continuation therapy with escitalopram gives significantly longer mean time to depressive relapse and fewer depressive relapses compared to placebo (the continuation study).
3. 3.The incidence of "mood switching" (defined as development of mixed episodes, mania, or hypomania according to DSM-IV criteria) do not differ significantly between escitalopram and placebo in either the acute or the continuation phases.

Conditions

Bipolar Disorder

Keywords

bipolar depression; SSRI; escitalopram; bipolar disorder; antidepressant; treatment trial; RCT

Outcome Measures

Primary Outcomes (6)

• Phase 1:

• response rates

• remission rates

• Phase 2:

• emergence of major depressive episodes

• emergence of mania, hypomania, and mixed states.

Secondary Outcomes (5)

• Phase 1:

• CGI-Improvement

• change on the IDS-SR

• Phase 2:

• Time spent at different depressive symptom levels as assessed by the DSM-IV diagnostic criteria.

Interventions

escitalopram DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bipolar disorder in major depressive episode according to DSM-IV
• MADRS score of at least 20 points at screening and baseline
• years of age
• Voluntary, informed and written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordfjord Psychiatric Centre: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Nordfjord Psychiatric Centre

Nordfjordeid, 6770, Norway

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Trond F. Aarre, MD

  Nordfjord Psychiatric Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: April 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 21, 2009

Record last verified: 2009-09

Locations

NO (1)