Status:
COMPLETED
Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
Lead Sponsor:
Yale University
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive disorder (TRD).
Detailed Description
This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, 8 week trial of adjunctive trial in treatment-resistant major depressive d...
Eligibility Criteria
Inclusion
- Group A inclusion/exclusion
- Age 18-65
- Written informed consent
- Meets DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for MDD, current
- Inventory of Depressive Symptomatology - Self-Rated (IDS-SR30) score of \> 20 at screening, baseline and start of double-blind phase (Phase 2)
- May have a history of failure to respond to up to two FDA-approved antidepressants at adequate doses during the current episode for at least 8 weeks, and for inclusion into the Phase 2 subjects must have failed the 8-week prospective citalopram treatment.
- Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of Phase 2.
Exclusion
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
- Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
- Patients who demonstrate \> 50% decrease in depressive symptoms as reflected by the IDS-SR total score from screen to baseline
- Serious suicide or homicide risk, as assessed by evaluating clinician A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
- History of a seizure disorder or clinical evidence of untreated hypothyroidism
- Patients requiring excluded medications (see Table 3 for details)
- Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
- Any investigational psychotropic drug within the last 3 months
- Have failed 3 or more adequate antidepressant trials during the current Major Depressive Episode by MGH-ATRQ criteria.
- Patients with a history of antidepressant-induced hypomania.
- Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level \>1.5 X ULN at initial screening, or \>5 x ULN during Phase 2 treatment.
- Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance.
- Patients currently being treated for a respiratory disorder (including asthma or COPD)
- Any subject who scores a 5 or higher on item #10 of the MADRS
- Group B inclusion/exclusion
- Inclusion criteria:
- Age 18-65
- Written informed consent
- Meets DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for MDD, current
- Inventory of Depressive Symptomatology - Self-Rated (IDS-SR30) score of \> 20 at screening and baseline visits, that is at the start of Phase 2
- Has a history of failure to respond to 1, 2, or 3 FDA-approved antidepressants at adequate doses during the current episode for at least 8 weeks, as defined by the MGH Antidepressant Treatment Response Questionnaire (MGH-ATRQ), and must be currently on the failed SSRI for at least 8 weeks and on a stable dose for at least 4 weeks.
- Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of Phase 2.
- Exclusion Criteria
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
- Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
- Serious suicide or homicide risk, as assessed by evaluating clinician A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
- History of a seizure disorder or clinical evidence of untreated hypothyroidism;
- Patients requiring excluded medications (see Table 3 for details)
- Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
- Any investigational psychotropic drug within the last 3 months
- Have failed 3 or more adequate antidepressant trials during the current Major Depressive Episode by MGH-ATRQ criteria.
- Patients with a history of antidepressant-induced hypomania.
- Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level \>2 X ULN at initial screening, or \>5 x ULN during Phase 2 treatment.
- Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patients safety or compliance.
- Patients currently being treated for a respiratory disorder (including asthma or COPD)
- Any subject who scores a 5 or higher on item #10 of the MADRS
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01204918
Start Date
June 1 2011
End Date
August 1 2015
Last Update
March 6 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University, Yale Depression Research Program
New Haven, Connecticut, United States, 06511
2
Massachussettes General Hospital, Depression Clinical and Research Center
Boston, Massachusetts, United States, 02114
3
Baylor College of Medicine
Houston, Texas, United States, 77030