Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026052
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-08
Brief Title:
Riluzole to Treat Major Depression
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 With Neurotrophic Properties in Major Depression
Status:
COMPLETED
Status Verified Date:
2003-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effectiveness of the drug riluzole Rilutek Registered Trademark for short-term treatment of depression symptoms such as depressed mood psychomotor retardation and excessive sleeping Despite the availability of a wide range of antidepressant drugs studies indicate that 30 to 40 percent of patients with major depression do not respond to first-line antidepressant treatment with drugs such as fluoxetine upropion venlafaxine and others Riluzole which is approved by the Food and Drug Administration FDA for amyotrophic lateral sclerosis ALS causes chemical changes in the brain that may also have antidepressant properties
Patients between 18 and 70 years of age with major depressive disorder without psychotic features may be eligible for this 2-stage 7-week study Candidates will be screened with a medical history and physical examination including an electrocardiogram EKG blood and urine tests and a psychiatric evaluation A
blood or urine sample will be tested for illegal drugsWomen of childbearing potential will have a pregnancy test
Participants will complete stage 1 of the study which lasts 1 week and may then continue with stage 2 for an additional 6 weeks At the start of the study patients will be tapered off all psychiatric medicines and will begin treatment with a placebo a sugar pill formulated to look like the active drug At some point they will be switched from placebo to riluzole In addition participants will undergo the following procedures
Physical examination and electrocardiograms EKG at the beginning and end of the study with vital signs temperature blood pressure and heart rate checked daily
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
Patients ages 18 to 70 with a diagnosis of major depression without psychotic features will in this pilot study single arm single blind receive riluzole 50-200 mgday for a period of 6 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment Therefore if 722 patients or greater have greater than 50 improvement on the primary efficacy measure then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial
Patients between 18 and 70 years of age with major depressive disorder without psychotic features may be eligible for this 2-stage 7-week study Candidates will be screened with a medical history and physical examination including an electrocardiogram EKG blood and urine tests and a psychiatric evaluation A
blood or urine sample will be tested for illegal drugsWomen of childbearing potential will have a pregnancy test
Participants will complete stage 1 of the study which lasts 1 week and may then continue with stage 2 for an additional 6 weeks At the start of the study patients will be tapered off all psychiatric medicines and will begin treatment with a placebo a sugar pill formulated to look like the active drug At some point they will be switched from placebo to riluzole In addition participants will undergo the following procedures
Physical examination and electrocardiograms EKG at the beginning and end of the study with vital signs temperature blood pressure and heart rate checked daily
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
Patients ages 18 to 70 with a diagnosis of major depression without psychotic features will in this pilot study single arm single blind receive riluzole 50-200 mgday for a period of 6 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment Therefore if 722 patients or greater have greater than 50 improvement on the primary efficacy measure then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial
Detailed Description:
Major affective disorders are common severe chronic and often life-threatening illnesses Major depression contributes to significant morbidity and mortality Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses Suicide is the cause of death in 10-20 of individuals with either bipolar or recurrent depressive disorders
Despite the availability of a wide range of antidepressant drugs clinical trials indicate that 30 to 40 of patients with major depression fail to respond to first-line antidepressant treatment despite adequate dosage duration and compliance Thus there is a clear need to develop novel and improved therapeutics for unipolar and bipolar depression Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system Furthermore a growing body of data suggests that mood disorders are associated with regional volumetric reductions and cell loss and atrophy It is thus noteworthy that lamotrigine which among other effects reduces glutamate release has antidepressant effects and a pilot study has suggested that NMDA antagonists may have antidepressant effects Together this data suggests 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
Riluzole an agent that is Food and Drug Administration-approved for Amyotrophic Lateral Sclerosis has significant antiglutamatergic and neuroprotective properties may prove to have antidepressant properties in depressed patients In this study we propose to investigate the potential antidepressant efficacy of riluzole an agent which reduces glutamatergic throughput via inhibition of its release which also exerts robus neurotrophic effects
This is a 6-week single-arm single-blind study that will examine the efficacy and safety of riluzole in patients with major depression without psychotic features
The study has two Study Periods Study Period I is the washout phase that will last 7 days Study Period II is a monotherapy 6-week acute treatment phase in which the efficacy and tolerability of riluzole is compared to baseline
Patients ages 18 to 60 with a diagnosis of major depression without psychotic features will in this pilot study single arm single-blind receive riluzole 50-200 mgday for a period of 6 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment Therefore if 722 patients or greater have greater than 50 improvement on the primary efficacy measure then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial
Despite the availability of a wide range of antidepressant drugs clinical trials indicate that 30 to 40 of patients with major depression fail to respond to first-line antidepressant treatment despite adequate dosage duration and compliance Thus there is a clear need to develop novel and improved therapeutics for unipolar and bipolar depression Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system Furthermore a growing body of data suggests that mood disorders are associated with regional volumetric reductions and cell loss and atrophy It is thus noteworthy that lamotrigine which among other effects reduces glutamate release has antidepressant effects and a pilot study has suggested that NMDA antagonists may have antidepressant effects Together this data suggests 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
Riluzole an agent that is Food and Drug Administration-approved for Amyotrophic Lateral Sclerosis has significant antiglutamatergic and neuroprotective properties may prove to have antidepressant properties in depressed patients In this study we propose to investigate the potential antidepressant efficacy of riluzole an agent which reduces glutamatergic throughput via inhibition of its release which also exerts robus neurotrophic effects
This is a 6-week single-arm single-blind study that will examine the efficacy and safety of riluzole in patients with major depression without psychotic features
The study has two Study Periods Study Period I is the washout phase that will last 7 days Study Period II is a monotherapy 6-week acute treatment phase in which the efficacy and tolerability of riluzole is compared to baseline
Patients ages 18 to 60 with a diagnosis of major depression without psychotic features will in this pilot study single arm single-blind receive riluzole 50-200 mgday for a period of 6 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment Therefore if 722 patients or greater have greater than 50 improvement on the primary efficacy measure then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial
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 |
|---|---|---|---|
| 02-M-0034 | None | None | None |