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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Shalvata Mental Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01311570
First received: January 9, 2011
Last updated: September 23, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Depression
Drug: Buprenorphine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

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: 20
Study Start Date: October 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine 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.

Other Name: subutex

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311570

Contacts
Contact: ziv carmel, M.D 00-972-9-7478644 zivca@clalit.org.il

Locations
Israel
Shalvata Medical Health Center Recruiting
Hod-Hasharon, Israel
Contact: ziv carmel, M.D.    00-972-9-7478644    zivca@clalit.org.il   
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: ziv carmel, M.D. shalvata medical health center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01311570     History of Changes
Other Study ID Numbers: B080910
Study First Received: January 9, 2011
Last Updated: September 23, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014