Levetiracetam in the Management of Bipolar Depression

This study has been completed.
Stanley Medical Research Institute
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
First received: November 29, 2007
Last updated: September 29, 2015
Last verified: September 2015
A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

Condition Intervention
Bipolar Depression
Drug: Levetiracetam
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levetiracetam in the Management of Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6. [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6. [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Who Achieve Remission. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

    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.

  • 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 ] [ Designated as safety issue: No ]
    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

Enrollment: 35
Study Start Date: October 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levetiracetam Drug: Levetiracetam
Flexible dose up to 2500mg per day, for 6 weeks.
Other Name: Keppra
Placebo Comparator: Placebo Drug: Placebo
Flexible dose up to 2500mg per day, for 6 weeks.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  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: NCT00566150

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Principal Investigator: Zubin Bhagwagar, MD PhD Yale University
  More Information

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00566150     History of Changes
Other Study ID Numbers: 05T-681, HIC#0508000506
Study First Received: November 29, 2007
Results First Received: October 2, 2009
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Bipolar Disorder
Affective Disorders
Mood Disorders
Double Blind
Acute Antidepressant Effects

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015