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

Phase 4

• Conditions: Schizophrenia
• Interventions: Drug: placebo; Drug: Minocycline

• Registration Number: NCT01133080
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-28
• Study Start: 2010-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Minocycline	Minocycline	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel

shalvata MHC; 🇮🇱 Hod HAsharon, Israel