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

This study has been terminated.
(The study has been terminated because too few patients have been recruited)
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Nordfjord Psychiatric Centre
ClinicalTrials.gov Identifier:
NCT00464191
First received: April 20, 2007
Last updated: September 19, 2009
Last verified: September 2009
  Purpose

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. 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 Intervention Phase
Bipolar Disorder
Drug: escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment

Resource links provided by NLM:


Further study details as provided by Nordfjord Psychiatric Centre:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 150
Study Start Date: April 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464191

Locations
Norway
Nordfjord Psychiatric Centre
Nordfjordeid, Norway, 6770
Sponsors and Collaborators
Nordfjord Psychiatric Centre
H. Lundbeck A/S
Investigators
Principal Investigator: Trond F. Aarre, MD Nordfjord Psychiatric Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00464191     History of Changes
Other Study ID Numbers: EudraCT 2005-004357-94, Lundbeck 10968, NPS 2005-1
Study First Received: April 20, 2007
Last Updated: September 19, 2009
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Nordfjord Psychiatric Centre:
bipolar depression
SSRI
escitalopram
bipolar disorder
antidepressant
treatment trial
RCT

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014