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Levetiracetam in the Management of Bipolar Depression

This study is currently recruiting participants.
Verified by Yale University, July 2008

Sponsors and Collaborators: Yale University
Stanley Medical Research Institute
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00566150
  Purpose

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

MedlinePlus related topics:   Bipolar Disorder    Depression   

ChemIDplus related topics:   Levetiracetam   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:   Levetiracetam in the Management of Bipolar Depression

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in depressive symptom scores from baseline. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in depressive symptom scores from baseline. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Number of subjects who achieve remission. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   October 2005
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator Drug: Levetiracetam
Flexible dose up to 2500mg per day, for 6 weeks.
P: Placebo Comparator Drug: Placebo
Flexible dose up to 2500mg per day, for 6 weeks.

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566150

Contacts
Contact: Kathleen Maloney, BA     203-974-7496     kathleen.maloney@yale.edu    
Contact: Jason Chen, BA     203-974-7559     jason.chen.jc64@yale.edu    

Locations
United States, Connecticut
Yale University School of Medicine     Recruiting
      New Haven, Connecticut, United States, 06519
      Principal Investigator: Zubin Bhagwagar, MD PhD            

Sponsors and Collaborators
Yale University
Stanley Medical Research Institute

Investigators
Principal Investigator:     Zubin Bhagwagar, MD PhD     Yale University    
  More Information

Publications:

Responsible Party:   Yale University ( Zubin Bhagwagar )
Study ID Numbers:   05T-681, HIC#0508000506
First Received:   November 29, 2007
Last Updated:   July 31, 2008
ClinicalTrials.gov Identifier:   NCT00566150
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Piracetam
Etiracetam
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on September 05, 2008




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