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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

May 26, 2010
January 4, 2012
June 2010
January 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01133080 on ClinicalTrials.gov Archive Site
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Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • 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.
  • Experimental: Minocycline
    Intervention: Drug: Minocycline
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
No
Contact: yechiel levkovitz, MD, PhD 972-9-7478644 levkovit@netvision.net.il
Israel
 
NCT01133080
SHA-0008-10
Yes
Shalvata Mental Health Center
Shalvata Mental Health Center
Not Provided
Principal Investigator: Yechiel Levkovitz, MD, PhD Shalvata MHC
Shalvata Mental Health Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP