Escitalopram as a Mood Stabilizer for Bipolar II Disorder

NCT00156325 | Completed Phase 2

• 1 other identifier: 03283
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorders

Keywords

Bipolar Disorder; Depression; Hypomania; Mood Stabilizer

Outcome Measures

Primary Outcomes (1)

• Frequency, Severity and duration of depressive and hypomanic episodes and impairment.

Interventions

Escitalopram (Lexapro) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression; Mania

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gordon Parker

  Black Dog Institute/School of Psychiatry, University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2004
• Study Completion: February 1, 2005
• Last Updated: January 2, 2006

Record last verified: 2005-09

Locations

AU (1)