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

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Minocycline
placebo
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shalvata Mental Health CenterRecruiting
  • shalvata MHC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minocycline

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Positive symptoms
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).

Secondary Outcome Measures

Full Information

First Posted
May 26, 2010
Last Updated
January 4, 2012
Sponsor
Shalvata Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01133080
Brief Title
Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minocycline
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Measure Information:
Title
Positive symptoms
Description
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).
Time Frame
from baseline to the end of the study (day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yechiel levkovitz, MD, PhD
Phone
972-9-7478644
Email
levkovit@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD, PhD
Organizational Affiliation
Shalvata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilik Levkovitz, prof.
Phone
972-9-7478644
Email
ylevk@clalit.org.il
Facility Name
shalvata MHC
City
Hod HAsharon
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yechiel levkovitz
Phone
972-9-7478644
First Name & Middle Initial & Last Name & Degree
yechiel levkovitz, MD, PhD

12. IPD Sharing Statement

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

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