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OpenTrials
Completed

NCT Number: NCT00274677

Depression And Bipolar Disorder

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Burbank, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • Patients must provide written and informed consent.
  • Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

  • Patients must not be suicidal.
  • Patients must not have a history of non-response to antidepressant treatment.
  • Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry.
  • Patients must not have had epilepsy or hypothyroidism.

Treatment and study plan

Placebo

Drug

Experimental treatment arm

Lamotrigine

Drug

Experimental treatment

Other names: Placebo

Primary outcomes

  1. Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Eight weeks

Secondary outcomes

  1. Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD (Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I)

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 11, 2006
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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