Riluzole to Treat Major Depression
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring Riluzole, Neuroprotective, Open-Label Study, Glutamate Dysfunction, Unipolar Depression, Antidepressant, Depression, Major Depression
Eligibility Criteria
INCLUSION CRITERIA Male or female subjects, 18 to 70 years of age will be eligible. Female subjects of childbearing potential must be using a medically accepted means of contraception. Each subject must have a level of understanding sufficient to agree to all required tests and examinations. Each subject must understand the nature of the study and must sign an informed consent document. Subjects must fulfill the criteria for major depression, recurrent without psychotic features as defined in DSM-IV (296.32, 296.33) based on clinical assessment and confirmed by structured diagnostic interview SCID-P. Subjects must have an initial score at Visit 1 and Visit 2 of at least 20 on the MADRS. Subjects must not have a decrease in the total score of MADRS of greater than or equal 20% during washout (between Visits 1 and 2). Subjects must have experienced, in the opinion of the investigator, at least one prior major depressive episode as defined in DSM-IV (not including the current major depressive episode). Subjects must have had at least one adequate antidepressant trial (SSRI, bupropion, or venlafaxine) during an episode of major depression (Thase and Rush, 1995; Thase et al., 2000). Subjects with current major depressive episode of no more than 24 months will be eligible. EXCLUSION CRITERIA Presence of psychotic features. Participate in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry (Visit 1). Female subjects who are either pregnant or nursing. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. Subjects with uncorrected hypothyroidism or hyperthyroidism. Abnormal levels of serum transaminases (ALT/SGPT; AST/SGOT), current or past blood dyscrasia. Documented history of hypersensitivity or intolerance to riluzole. DSM-IV substance abuse or dependence within the past 90 days. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to Visit 2. Treatment with a reversible MAOI, guanethidine, or guanadrel within 1 week or with fluoxetine within 3 weeks prior to Visit 2. Treatment with any other concomitant medication with primarily CNS activity, other than specified in Appendix A. Treatment with clozapine or ECT within 12 weeks prior to Visit 2. Current diagnosis of schizophrenia or other psychotic disorder as defined in the DSM-IV will be excluded. Judged clinically to be at serious suicidal risk, with a score of 3 or more on item 3 of the HAMD will be excluded. Patients will not be allowed to receive structured psychotherapy during the trial.
Sites / Locations
- National Institute of Mental Health (NIMH)