NCT00566150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

March 31, 2020

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

November 29, 2007

Results QC Date

October 2, 2009

Last Update Submit

March 27, 2020

Conditions

Bipolar Depression

Keywords

KeppraLevetiracetamAnticonvulsantDepressionBipolar DisorderAffective DisordersMood DisordersDouble BlindAcute Antidepressant Effects

Outcome Measures

Primary Outcomes (1)

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

    Baseline to week 6

Secondary Outcomes (3)

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

    Baseline to week 6

  • Number of Subjects Who Achieve Remission.

    Week 6

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

    Baseline to week 6

Study Arms (2)

Levetiracetam

ACTIVE COMPARATOR
Drug: Levetiracetam

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LevetiracetamDRUG

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

Also known as: Keppra
Levetiracetam
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

  • Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002.

    PMID: 17140277BACKGROUND

  • Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.

    PMID: 21034692DERIVED

MeSH Terms

Conditions

Bipolar DisorderDepressionMood Disorders

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Zubin Bhagwagar
Organization
Yale University
zubin.bhagwagar@yale.edu
203-974-7560

Study Officials

  • Zubin Bhagwagar, MD PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

October 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

March 31, 2020

Results First Posted

November 2, 2015

Record last verified: 2016-08

Locations

US(1)