Study Assessing the Safety and Therapeutic Effect of Buprenorphine in MDD Patients
This study is not yet open for participant recruitment.
Verified September 2012 by Shalvata Mental Health Center
Information provided by (Responsible Party):
Shalvata Mental Health Center
First received: January 9, 2011
Last updated: September 23, 2012
Last verified: September 2012
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Single Center, Open Label, Dose-titration, add-on Study Assessing the Feasibility, Safety and Therapeutic Effect of Buprenorphine in Adult Patients With Diagnosis of Major Depression.
Primary Outcome Measures:
- The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population. [ Time Frame: from baseline to day 42 [end of Buprenorphine treatment] ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population. [ Time Frame: from baseline to day 42 [end of Buprenorphine treatment] ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
In the first 2 weeks all subjects will enter into a dose titration phase, starting with minimum dosage of 1mg/day Buprenorphine gradually increasing to 4-8 mg/day according to tolerance and clinical benefit.
From week 3 to week 8, all subjects are prescribed Buprenorphine sublingually, OID in a stable dosage according to the decision of the treating physician.
Other Name: subutex
|Ages Eligible for Study:
||18 Years to 68 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311570
|Shalvata Medical Health Center
|Hod-Hasharon, Israel |
|Contact: ziv carmel, M.D. 00-972-9-7478644 firstname.lastname@example.org |
Shalvata Mental Health Center
||ziv carmel, M.D.
||shalvata medical health center
No publications provided
||Shalvata Mental Health Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 9, 2011
||September 23, 2012
||Israel: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants