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OpenTrials
Completed

NCT Number: NCT00056277

Bipolar Disorder Study for Men and Women

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

Completed

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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, Beverly Hills, 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 criteria

  • Patients must provide written and informed consent
  • Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
  • Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior

Exclusion criteria

  • Patients must not be suicidal
  • Patients must not have a history or 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

Lamotrigine

Drug

Primary outcomes

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

    Time frame: 8 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: 8 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 11, 2003
Registry last updated
Apr 7, 2017

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

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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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