Bipolar Depression Research Study - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Riluzole

U.S. FDA Resources

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. Response will be defined as a > 50% reduction in MADRS score from baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the CGI, rates of full remission as defined by a MADRS score < 12, rates of hypomanic/manic symptoms using the YMRS, clinical data as predictors of treatment response, smoking as a factor that may limit effectiveness. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 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 Name: Rilutek
Placebo Comparator: 2	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.

Arms

Assigned Interventions

Experimental: 1

Drug: Riluzole

Initially dispensed 50 mg 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 Name: Rilutek

Placebo Comparator: 2

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
Genders Eligible for Study:	Both
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

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

Additional Information:

Bipolar Depression Research Study Main Web Page This link exits the ClinicalTrials.gov site

Publications:

Zarate CA Jr, Quiroz JA, Singh JB, Denicoff KD, De Jesus G, Luckenbaugh DA, Charney DS, Manji HK. An open-label trial of the glutamate-modulating agent riluzole in combination with lithium for the treatment of bipolar depression. Biol Psychiatry. 2005 Feb 15;57(4):430-2.

Zarate CA Jr, Payne JL, Quiroz J, Sporn J, Denicoff KK, Luckenbaugh D, Charney DS, Manji HK. An open-label trial of riluzole in patients with treatment-resistant major depression. Am J Psychiatry. 2004 Jan;161(1):171-4.

Responsible Party:	Jennifer Payne, M.D., Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier:	NCT00376220 History of Changes
Other Study ID Numbers:	04-04-23-10
Study First Received:	September 13, 2006
Last Updated:	June 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Bipolar
Depression

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Riluzole
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013