Efficacy and Tolerability of Riluzole in Treatment Resistant Depression

Exclusion Criteria

• •1. 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)
• •2. Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
• •3. Patients who demonstrate \> 50% decrease in depressive symptoms as reflected by the IDS-SR total score from screen to baseline
• •4. 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.
• •5. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
• •6. 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)
• •7. History of a seizure disorder or clinical evidence of untreated hypothyroidism
• •8. Patients requiring excluded medications (see Table 3 for details)
• •9. Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
• •10. Any investigational psychotropic drug within the last 3 months
• •11. Have failed 3 or more adequate antidepressant trials during the current Major Depressive Episode by MGH-ATRQ criteria.
• •12. Patients with a history of antidepressant-induced hypomania.
• •13. 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.
• •14. Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance.
• •15. Patients currently being treated for a respiratory disorder (including asthma or COPD)
• •16. Any subject who scores a 5 or higher on item #10 of the MADRS
• •Group B inclusion/exclusion
• •1. 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)
• •2. Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
• •3. 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.
• •4. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
• •5. 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)
• •6. History of a seizure disorder or clinical evidence of untreated hypothyroidism;
• •7. Patients requiring excluded medications (see Table 3 for details)
• •8. Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
• •9. Any investigational psychotropic drug within the last 3 months
• •10. Have failed 3 or more adequate antidepressant trials during the current Major Depressive Episode by MGH-ATRQ criteria.
• •11. Patients with a history of antidepressant-induced hypomania.
• •12. 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.
• •13. Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patients safety or compliance.
• •14. Patients currently being treated for a respiratory disorder (including asthma or COPD)
• •15. Any subject who scores a 5 or higher on item #10 of the MADRS