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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133080
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : May 28, 2010
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Minocycline Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Positive symptoms [ Time Frame: from baseline to the end of the study (day 56) ]
    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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01133080

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Contact: yechiel levkovitz, MD, PhD 972-9-7478644

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Shalvata Mental Health Center Recruiting
Hod Hasharon, Israel
Contact: Hilik Levkovitz, prof.    972-9-7478644   
shalvata MHC Not yet recruiting
Hod HAsharon, Israel
Contact: yechiel levkovitz    972-9-7478644      
Principal Investigator: yechiel levkovitz, MD, PhD         
Sponsors and Collaborators
Shalvata Mental Health Center
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Principal Investigator: Yechiel Levkovitz, MD, PhD Shalvata MHC

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Responsible Party: Shalvata Mental Health Center Identifier: NCT01133080    
Other Study ID Numbers: SHA-0008-10
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anti-Bacterial Agents
Anti-Infective Agents