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

Sponsor
Shalvata Mental Health Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01133080
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
31
Duration (Months)
25
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2010
Anticipated Primary Completion Date :
Jan 1, 2013
Anticipated Study Completion Date :
Jan 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Positive symptoms [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shalvata Mental Health Center Hod Hasharon Israel
2 shalvata MHC Hod HAsharon Israel

Sponsors and Collaborators

  • Shalvata Mental Health Center

Investigators

  • Principal Investigator: Yechiel Levkovitz, MD, PhD, Shalvata MHC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01133080
Other Study ID Numbers:
  • SHA-0008-10
First Posted:
May 28, 2010
Last Update Posted:
Jan 5, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:
Schizophrenia
Minocycline

Study Results

No Results Posted as of Jan 5, 2012