Minocycline for the Treatment of Early-Phase Schizophrenia

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Current antipsychotics have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. Recent findings in animal models and human case-reports suggest its potential for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia. The study will utilize a longitudinal double blind, randomized, placebo-controlled design with patients followed for six-months. Early-phase schizophrenia patients were recruited and randomly allocated to a minocycline or placebo treatment (2:1 ratio; 200 mg/day). The primary outcome measures are the Scale for Assessment of Negative Symptoms (SANS) and assessments of executive functions.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shalvata Mental Health Center
• Collaborator: Abarbanel Mental Health Center
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. age between 18-35 years;

2. current DSM-IV diagnosis of schizophrenia confirmed by the Structured Clinical Interview for DSM-IV (SCID) conducted by a trained psychiatrist.

3. being at an early phase of the disorder (i.e., within five years of their first exposure to neuroleptic treatment;18)

4. did not receive antipsychotic treatment for six months preceding current symptom exacerbation;

5. baseline total score of more than 60 on the Positive and Negative Syndrome Scale (PANSS).

6. Initiation of treatment with atypical antipsychotic medication equal or less than 14 days prior to study entry (risperidone, olanzapine, quetiapine, or clozapine; 200-600 mg/day chlorpromazine equivalent doses);

7. able to comprehend the procedure and aims of the study.

Exclusion Criteria:

1. acute, unstable, significant or untreated medical illness beside schizophrenia;

2. pregnant or breast-feeding females;

3. A DSM-IV diagnosis of substance abuse or dependency;

4. Known contraindication to minocycline treatment.

5. Treatment with minocycline or Beta-lactam antibiotics in the preceding half year before study entry.

6. Under compulsory hospitalization.