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Completed

NCT Number: NCT00566150

Levetiracetam in the Management of Bipolar Depression

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DSM-IV diagnosis of bipolar disorder
  • Presence of a current major depressive episode on the SCID
  • Score of 17 or great on the HDRS
  • Capable of giving voluntary written consent

Exclusion criteria

  • Significant current substance dependence/abuse within 3 months preceding the trial
  • Active suicidal ideation
  • Pregnant/lactating mothers
  • Significant medical history

Treatment and study plan

Levetiracetam

Drug

Flexible dose up to 2500mg per day, for 6 weeks.

Other names: Keppra

Placebo

Drug

Flexible dose up to 2500mg per day, for 6 weeks.

Primary outcomes

  1. Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.

    Time frame: Baseline to week 6

    Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.

Secondary outcomes

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.

    Time frame: Baseline to week 6

    Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.

  2. Number of Subjects Who Achieve Remission.

    Time frame: Week 6

    Remission response is measured as an HDRS-21 total score is less than or equal to 7.

    HDRS-21 measures range of depressive symptoms. Endpoint is LOCF.

  3. Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.

    Time frame: Baseline to week 6

    Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 3, 2007
Registry last updated
Mar 31, 2020

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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