Escitalopram as a Mood Stabilizer for Bipolar II Disorder

This study has been completed.
Sponsor:
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00156325
First received: September 8, 2005
Last updated: December 30, 2005
Last verified: September 2005
  Purpose

This study will investigate the efficacy of Escitalopram, a Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant, in the treatment of Bipolar II Disorder.

The use of antidepressants for those with bipolar disorder appears common in clinical practice but is not countenanced - at least as monotherapy - in formal treatment guidelines. This view reflects concerns about the possibility of antidepressant drugs inducing switching and rapid cycling in those with Bipolar Disorder. Although the effectiveness of treating Bipolar II patients with SSRIs has received very little attention in the literature, observations of Bipolar II patients treated with SSRIs suggest they may have general mood stabilising properties. Many patients have reported improvements not only in their depressed mood, but also a reduction in the severity, duration and frequency of hypomanic episodes.

In this proof of concept study we specifically assess whether a standard dose of an SSRI antidepressant is more effective than placebo in reducing the frequency, severity and duration of both depressive and hypomanic episodes.


Condition Intervention Phase
Bipolar Disorders
Drug: Escitalopram (Lexapro)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Escitalopram as a Mood Stabilizer for Bipolar II Disorder

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Frequency, Severity and duration of depressive and hypomanic episodes and impairment.

Estimated Enrollment: 10
Study Start Date: February 2004
Estimated Study Completion Date: February 2005
Detailed Description:

This study is a randomized, double-blind, placebo-controlled, cross-over trial of Escitalopram (10 mg) versus placebo (identical presentation) in subjects identified as having Bipolar II Disorder. The nine-month study will commence with a no-treatment baseline period of three months (Baseline Phase) to ensure that subjects meet criteria for episode frequency. Subjects compliant with and completing baseline period requirements will then be randomized to receive Escitalopram or placebo for three months (Phase 2) and will then subsequently cross over to receive the alternative compound for the final three-month period (Phase 3). Prior to that cross-over, there will be a two-day taper period to avoid potential withdrawal effects, followed by a seven-day wash-out period to avoid carry-over effects from drug to placebo. Subjects will be assessed at the start of the study, and every month thereafter for the entire nine-month period.

Subjects aged 18-65 meeting diagnostic criteria for Bipolar II disorder will be recruited. Diagnosis will be based on the Diagnostic and Statistical Manual of Mental Disorders with the exception of the minimum four-day duration criterion for hypomanic episodes. Subjects must have a minimum 2-year history of depressive and hypomanic episodes, with a mood disturbance (either ‘high’ or ‘low’) occurring at least monthly. Subjects will be excluded if they have previously been treated with anti-depressants or mood-stabilisers, or have a history of psychotic symptoms during episodes of either hypomania or depression. Subjects who are actively suicidal, have a significant personality disorder, substantive illicit drug use, or alcohol consumption >30g/day will also be excluded. Exclusion will also apply to subjects who are pregnant or breastfeeding, and those with a history of heart disease, liver disease, epilepsy or seizures.

Subjects will complete a number of self-report questionnaires about their mood and functioning on a monthly basis as well as monitoring their mood on a daily basis. A research psychologist or psychiatrist will complete (at monthly intervals) the Hamilton Depression Rating, Young Mania Rating Scale and the DSM-IV Social and Occupational Functioning Assessment Scale based on functioning over the previous week throughout the nine-month duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18-65
  • Minimum two year history of depressive and hypomanic episodes
  • Mood episodes occuring monthly
  • Meet DSM-IV criteria for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes)

Exclusion Criteria:

  • Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication
  • History of psychotic symptoms during hypomanic or depressive episodes
  • Current suicidal behaviours
  • Current substantive illicit drug use or alcohol consumption
  • Significant personality disorder
  • Pregnancy or breastfeeding
  • History of heart disease, liver disease, epilepsy or seizures
  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: NCT00156325

Locations
Australia, New South Wales
University of New South Wales
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
Investigators
Principal Investigator: Gordon Parker Black Dog Institute/School of Psychiatry, University of New South Wales
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156325     History of Changes
Other Study ID Numbers: 03283
Study First Received: September 8, 2005
Last Updated: December 30, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
Bipolar Disorder
Depression
Hypomania
Mood Stabilizer

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

ClinicalTrials.gov processed this record on September 16, 2014