NCT00544544

Brief Summary

Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 18, 2010

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

October 12, 2007

Results QC Date

June 24, 2010

Last Update Submit

August 6, 2018

Conditions

Bipolar Depression

Keywords

Bipolardepression

Outcome Measures

Primary Outcomes (1)

  • Change in Hamilton Depression Rating Scale

    The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.

    Baseline (week 0) - week 6

Secondary Outcomes (3)

  • Montgomery Asberg Depression Rating Scale

    Baseline (week 0) - week 6

  • Young Mania Rating Scale

    Baseline (week 0) - week 6

  • Clinical Global Impression Scale

    Baseline (week 0) - week 6

Study Arms (1)

Riluzole

EXPERIMENTAL

Riluzole 50 mg twice daily for 2 weeks, increased to riluzole 50 mg in the morning and 100 mg in the evening for 1 week if tolerated, with a further increase to riluzole 100 mg twice daily if tolerated for 3 weeks.

Drug: Riluzole

Interventions

RiluzoleDRUG

50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks

Also known as: Rilutek
Riluzole

Eligibility Criteria

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

You may qualify if:

  • Male or female age 18-65
  • Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
  • Current score of \>/= 18 on the Hamilton Depression Scale

You may not qualify if:

  • Active psychotic/manic symptoms
  • Lifetime history of schizophrenia or obsessive compulsive disorder
  • Clinically significant medical disease
  • Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

  • Brennan BP, Hudson JI, Jensen JE, McCarthy J, Roberts JL, Prescot AP, Cohen BM, Pope HG Jr, Renshaw PF, Ongur D. Rapid enhancement of glutamatergic neurotransmission in bipolar depression following treatment with riluzole. Neuropsychopharmacology. 2010 Feb;35(3):834-46. doi: 10.1038/npp.2009.191. Epub 2009 Dec 2.

    PMID: 19956089RESULT

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Brian P. Brennan, M.D.
Organization
McLean Hospital
bbrennan@partners.org
617-855-2911

Study Officials

  • Dost Ongur, M.D, Ph.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Translational Neuroscience Research

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

August 7, 2018

Results First Posted

August 18, 2010

Record last verified: 2018-08

Locations

US(1)