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

Shalvata Mental Health Center2 sites in 1 country50 target enrollmentJune 2010

ConditionsSchizophrenia

InterventionsMinocycline placebo

DrugsMinocycline placebo

Overview

Phase: Phase 4
Intervention: Minocycline
Conditions: Schizophrenia
Sponsor: Shalvata Mental Health Center
Enrollment: 50
Locations: 2
Primary Endpoint: Positive symptoms
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

January 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shalvata Mental Health Center

Responsible Party

Sponsor

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.

Arms & Interventions

Minocycline

Intervention: Minocycline

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

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).