We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00566150
Previous Study | Return to List | Next Study

Levetiracetam in the Management of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00566150
Recruitment Status : Completed
First Posted : December 3, 2007
Results First Posted : November 1, 2015
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Depression Drug: Levetiracetam Drug: Placebo Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levetiracetam in the Management of Bipolar Depression
Study Start Date : October 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566150


Locations
Layout table for location information
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Zubin Bhagwagar, MD PhD Yale University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00566150    
Other Study ID Numbers: 0508000506
First Posted: December 3, 2007    Key Record Dates
Results First Posted: November 1, 2015
Last Update Posted: March 31, 2020
Last Verified: August 2016
Keywords provided by Yale University:
Keppra
Levetiracetam
Anticonvulsant
Depression
Bipolar Disorder
 Affective Disorders
Mood Disorders
Double Blind
Acute Antidepressant Effects
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Bipolar and Related Disorders
Levetiracetam
Anticonvulsants
Nootropic Agents