Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054704
Status:
TERMINATED
Last Update Posted:
2019-04-25
First Post:
2003-02-06
Brief Title:
Riluzole to Treat Depression in Bipolar Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Investigation of the Antidepressant Efficacy of an Antiglutamatergic Agent in Bipolar Depression
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Placebo was better than active drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examines if Riluzole FDA approved for ALS will improve symptoms of depression in Bipolar Disorder
Purpose This study will examine the safety and effectiveness of riluzole Rilutek trademark for short-term treatment of depression symptoms such as depressed mood psychomotor retardation and excessive sleeping in patients with bipolar disease Riluzole is approved by the Food and Drug Administration FDA to treat amyotrophic lateral sclerosis ALS also known as Lou Gehrigs disease Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients
Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study Candidates must be currently depressed must have had at least one previous major depressive episode and must have failed to improve with prior treatment with at least one antidepressant They will be screened with a medical history physical examination electrocardiogram EKG blood and urine tests and psychiatric evaluation A blood or urine sample will be analyzed for illegal drugs Women of childbearing potential will have a pregnancy test
Participants will begin an 8-week course of treatment starting with a placebo a sugar pill formulated to look like the active drug and at some point switching to riluzole In addition to drug treatment participants will undergo the following procedures
Physical examination and electrocardiogram EKG at the beginning and end of the study
Weekly check of vital signs temperature blood pressure and heart rate
Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response
Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects
At the end of the study participants psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged
Atendemos pacientes de habla hispana
We enroll eligible participants locally and from around the country Travel arrangements are provided and costs covered by the National Institute of Mental Health NIMH Arrangements vary by distance and by specific study After completing the study participants receive short-term follow-up care while transitioning back to a provider
Purpose This study will examine the safety and effectiveness of riluzole Rilutek trademark for short-term treatment of depression symptoms such as depressed mood psychomotor retardation and excessive sleeping in patients with bipolar disease Riluzole is approved by the Food and Drug Administration FDA to treat amyotrophic lateral sclerosis ALS also known as Lou Gehrigs disease Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients
Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study Candidates must be currently depressed must have had at least one previous major depressive episode and must have failed to improve with prior treatment with at least one antidepressant They will be screened with a medical history physical examination electrocardiogram EKG blood and urine tests and psychiatric evaluation A blood or urine sample will be analyzed for illegal drugs Women of childbearing potential will have a pregnancy test
Participants will begin an 8-week course of treatment starting with a placebo a sugar pill formulated to look like the active drug and at some point switching to riluzole In addition to drug treatment participants will undergo the following procedures
Physical examination and electrocardiogram EKG at the beginning and end of the study
Weekly check of vital signs temperature blood pressure and heart rate
Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response
Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects
At the end of the study participants psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged
Atendemos pacientes de habla hispana
We enroll eligible participants locally and from around the country Travel arrangements are provided and costs covered by the National Institute of Mental Health NIMH Arrangements vary by distance and by specific study After completing the study participants receive short-term follow-up care while transitioning back to a provider
Detailed Description:
The treatments for acute unipolar depression have been extensively researched However despite the availability of a wide range of antidepressant drugs clinical trials indicate that 30 to 40 of depressed patients fail to respond to first-line antidepressant treatment despite adequate dosage duration and compliance Very few studies have examined the efficacy of somatic treatments for the acute phase of bipolar depression Thus there is a clear need to develop novel and improved therapeutics for bipolar depression Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system Clinical data suggests that lamotrigine an inhibitor of glutamate release and the N-methyl-D-aspartate NMDA antagonist ketamine may have antidepressant effects Finally our group recently found in two separate studies that the glutamate modulating agent riluzole was effective in treatment-resistant unipolar and bipolar depression Zarate et al 2004 Together these data suggest that the glutamatergic system may play a role in the pathophysiology and treatment of depression and that agents which more directly reduce glutamatergic neurotransmission may represent a novel class of antidepressants
In this study we propose to extend our findings from open-label studies with riluzole in treatment-resistant depression by investigating its efficacy in a double-blind placebo-controlled study in bipolar depression
Patients ages 18 to 70 years with a diagnosis of bipolar disorder I or II current episode depressed without psychotic features will be randomized to double-blind treated to receive either riluzole 50-200 mgday or placebo for a period of 8 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Approximately 78 patients with acute bipolar depression will be enrolled in this study
In this study we propose to extend our findings from open-label studies with riluzole in treatment-resistant depression by investigating its efficacy in a double-blind placebo-controlled study in bipolar depression
Patients ages 18 to 70 years with a diagnosis of bipolar disorder I or II current episode depressed without psychotic features will be randomized to double-blind treated to receive either riluzole 50-200 mgday or placebo for a period of 8 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Approximately 78 patients with acute bipolar depression will be enrolled in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0092 | OTHER | NIH CNS IRB | None |