NCT01311570

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

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Buprenorphine	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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-02-01
• First posted: 2011-03-09
• Last updated: 2012-09-25

Locations

1 site across 1 country: Israel