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Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study

This study is currently recruiting participants.
Verified January 2012 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01133080
First received: May 26, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

Double - Blind, Randomized, single centered study. The purpose of this study is to assess the feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for positive symptoms in adults suffering from schizophrenia.


Condition Intervention Phase
Schizophrenia
 Drug: Minocycline
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Positive symptoms [ Time Frame: from baseline to the end of the study (day 56) ] [ Designated as safety issue: No ]
    Positive symptoms: The change in Scale for the Positive and Negative Syndrome Scale (PANSS) score from baseline to the end of the study and the change in Clinical Global Impression Scale (CGI).


Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline Drug: Minocycline
minocycline 200 mg/day orally in two divided doses for the second week. From weeks 3 to weeks 5, minocycline 400 mg/day orally in two divided doses.
Placebo Comparator: Placebo Drug: placebo

placebo 200 mg/day orally in two divided doses for the first week. placebo 200 mg/day orally in two divided doses for the second week.

From weeks 3 to weeks 5, placebo 400 mg/day orally in two divided doses.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 20-65 years of age.
  • Primary DSM-IV diagnosis of Schizophrenia based on SCID for schizophrenia and confirmed by two senior psychiatrists.
  • Patients who scored "moderate" (4) or higher on at least three of seven positive items in PANSS
  • Initiated on treatment with atypical anti-psychotic medication.
  • Capable and willing to provide informed consent
  • Able to adhere to the treatment schedule
  • Able to read, hear, write and speak the local language.
  • Has signed a written informed consent to participate in the study

Exclusion Criteria:

  • Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia including alcohol and drug dependence, or depression.
  • Current suicidal ideation or history of a suicide attempt in the past 3 years
  • Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse. or women who are breastfeeding
  • Subjects who were taking a known contraindication to minocycline treatment.
  • Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
  • Subjects who were under compulsory hospitalization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133080

Contacts
Contact: yechiel levkovitz, MD, PhD 972-9-7478644 levkovit@netvision.net.il

Locations
Israel
shalvata MHC Not yet recruiting
Hod HAsharon, Israel
Contact: yechiel levkovitz     972-9-7478644        
Principal Investigator: yechiel levkovitz, MD, PhD            
Shalvata Mental Health Center Recruiting
Hod Hasharon, Israel
Contact: Hilik Levkovitz, prof.     972-9-7478644     ylevk@clalit.org.il    
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Yechiel Levkovitz, MD, PhD Shalvata MHC
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01133080     History of Changes
Other Study ID Numbers: SHA-0008-10
Study First Received: May 26, 2010
Last Updated: January 4, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Minocycline
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013