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A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00376220
First received: September 13, 2006
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
The Johns Hopkins Department of Psychiatry is conducting a research study to examine the effectiveness of riluzole in treating the depressed phase of bipolar disorder. This outpatient treatment study of medication or placebo will last 9-12 weeks. The study includes medical and psychiatric evaluations as well as time-limited medication treatment at no cost, and you will be compensated for your participation.

Condition Intervention Phase
Bipolar Disorder Drug: Riluzole Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy. [ Time Frame: 8 weeks ]
    The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a > 50% reduction in MADRS score from baseline.


Enrollment: 94
Study Start Date: May 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Drug: Riluzole Initially dispensed 50 mg capsules to take twice a day (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules in the morning (qAM), two capsules in the evening (qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as Montgomery Asberg Depression Rating Scale (MADRS) < 12) the dose will not be increased further unless clinical symptoms recur.

Other Names:

• Rilutek

Drug: Riluzole
Initially dispensed 50 mg capsules to take twice a day (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules in the morning (qAM), two capsules in the evening (qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as Montgomery Asberg Depression Rating Scale (MADRS) < 12) the dose will not be increased further unless clinical symptoms recur.
Other Name: Rilutek
Placebo Comparator: 2
Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
Other: Placebo
Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.

Detailed Description:
The study will last 8 to 12 weeks and requires weekly visits. Participants will come to Johns Hopkins for a screening visit during which they will talk with a psychiatrist, answer questions about their mood and symptoms, have their blood drawn and have a brief physical exam. If they meet criteria for the study, any antidepressant medication that they are taking will be tapered and stopped before beginning study medications. Participation in the study includes free study medication, labs, and testing plus reimbursement for transportation. Participants will also be paid and after the study referred back to their treating psychiatrist with treatment recommendations.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-75
  • Diagnosed with Bipolar I or II disorder and currently depressed
  • Tried at least one antidepressant during the current episode of depression
  • Currently taking either lithium, depakote, or tegretol
  • Currently in outpatient treatment with a psychiatrist

Exclusion Criteria:

  • Current psychotic symptoms
  • Women who are pregnant or nursing
  • Any serious, uncontrolled medical illness
  • History of liver problems
  • Current or past blood diseases
  • Current drug or alcohol abuse
  • Currently receiving Electroconvulsive Shock Therapy (ECT)
  • Judged to be at serious suicidal risk
  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: NCT00376220

Locations
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Stanley Medical Research Institute
Investigators
Principal Investigator: Jennifer L Payne, MD Johns Hopkins School of Medicine
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00376220     History of Changes
Other Study ID Numbers: 04-04-23-10
Study First Received: September 13, 2006
Results First Received: September 20, 2016
Last Updated: February 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
Bipolar
Depression

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on June 27, 2017