Study Assessing the Safety and Therapeutic Effect of Buprenorphine in MDD Patients

Inclusion Criteria:

• Outpatients and inpatients
• Men and women 18-68 years of age.
• Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
• Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
• The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
• If currently taking Benzodiazepines, the patient must be clinically appropriate to discontinue treatment with those agents, and able to tolerate no benzodiazepines during the study period.
• Capable and willing to provide informed consent
• Able to adhere to the treatment schedule.

Exclusion Criteria:

• Depression secondary to a general medical condition.
• History of substance abuse or dependence within the past 6 month (except nicotine and caffeine).
• All antidepressant medications, must have been in stable dosage for at least 6 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
• Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
• Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
• Presence (within 12 months of baseline) of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
• Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the screening visit
• Use of a CYP3A4 Inhibitors and CYP3A4 Inducers within 2 weeks of screening visit.
• Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
• Known or suspected pregnancy
• Women who are breast-feeding
• Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
• Patients with severe respiratory insufficiency or asthma - anticipation require examination of pulmonologist.
• Patients with severe hepatic or renal insufficiency.
• Patients with history of head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis- anticipation require examination of neurologist.