Study Assessing the Safety and Therapeutic Effect of Buprenorphine in MDD Patients
|ClinicalTrials.gov Identifier: NCT01311570|
Recruitment Status : Unknown
Verified September 2012 by Shalvata Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : March 9, 2011
Last Update Posted : September 25, 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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Buprenorphine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||February 2013|
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
- 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] ]
- 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] ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311570
|Contact: ziv carmel, M.Demail@example.com|
|Shalvata Medical Health Center||Recruiting|
|Contact: ziv carmel, M.D. 00-972-9-7478644 firstname.lastname@example.org|
|Principal Investigator:||ziv carmel, M.D.||shalvata medical health center|