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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464191
Recruitment Status : Terminated (The study has been terminated because too few patients have been recruited)
First Posted : April 23, 2007
Last Update Posted : September 21, 2009
H. Lundbeck A/S
Information provided by:
Nordfjord Psychiatric Centre

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.


  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. Continuation therapy with escitalopram gives significantly longer mean time to depressive relapse and fewer depressive relapses compared to placebo (the continuation study).
  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.

Patients: In- and outpatients receiving care in the specialised psychiatric services of Western Norway. The population is intended to be representative of the patients treated for bipolar depression in ordinary specialist care. Patients must have a MADRS score of at least 20 at baseline. Patients with ongoing substance abuse or dependence, organic mental illness, and non-affective psychotic symptoms are excluded.

Medication: Escitalopram 10-20 mg daily or placebo in addition to mood stabilisers. The dose of mood stabilisers must have been constant for the last six weeks prior to randomisation.

Method: Phase 1 is a eight-week acute treatment trial with six clinical assessments. Patients treated with escitalopram who have not responded after eight weeks (defined by at least 50% reduction of MADRS score compared to baseline) leave the study. Placebo non-responders are treated openly with escitalopram and repeat phase 1. Responders are re-randomised to 32 weeks of maintenance treatment (phase 2). Phase 2 has nine clinical assessments. Patients who develop hypomania, mania or depressive episodes (defined as episodes meeting DSM-IV criteria for Major Depressive Episode with MADRS scores of at least 20 points) leave the study in this phase. Patients leaving the study prematurely will be offered alternative treatment.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: escitalopram Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment
Study Start Date : April 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Phase 1:
  2. response rates
  3. remission rates
  4. Phase 2:
  5. emergence of major depressive episodes
  6. emergence of mania, hypomania, and mixed states.

Secondary Outcome Measures :
  1. Phase 1:
  2. CGI-Improvement
  3. change on the IDS-SR
  4. Phase 2:
  5. Time spent at different depressive symptom levels as assessed by the DSM-IV diagnostic criteria.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00464191

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Nordfjord Psychiatric Centre
Nordfjordeid, Norway, 6770
Sponsors and Collaborators
Nordfjord Psychiatric Centre
H. Lundbeck A/S
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Principal Investigator: Trond F. Aarre, MD Nordfjord Psychiatric Centre
Layout table for additonal information Identifier: NCT00464191    
Other Study ID Numbers: EudraCT 2005-004357-94
Lundbeck 10968
NPS 2005-1
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009
Keywords provided by Nordfjord Psychiatric Centre:
bipolar depression
bipolar disorder
treatment trial
Additional relevant MeSH terms:
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Bipolar Disorder
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs