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Minocycline for the Treatment of Early-Phase Schizophrenia

This study has been completed.
Abarbanel Mental Health Center
Information provided by:
Shalvata Mental Health Center Identifier:
First received: August 11, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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.

Condition Intervention Phase
Negative and Cognitive Symptoms in Schizophrenia Drug: Minocycline Drug: Placebo (200 mg/day) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Double Blind Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Early-Phase Schizophrenia

Resource links provided by NLM:

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Change in SANS scores over the 6-month study ]

Secondary Outcome Measures:
  • PANSS, CGI, CDS, ITAQ, CANTAB measures, adverse events. [ Time Frame: Change during the 6-month duration of the study ]

Enrollment: 70
Study Start Date: August 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Minocycline treatment
Drug: Minocycline
Minocycline as an add-on drug (200 mg/day)
Placebo Comparator: 2
Drug: Placebo (200 mg/day)

  Show Detailed Description


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00733057

The Emotion-Cognition Research Center, The Shalvata Mental Health Care Center, P.O.B. 94.
Hod-Hasharon, Israel, 70300
Sponsors and Collaborators
Shalvata Mental Health Center
Abarbanel Mental Health Center
Principal Investigator: Yechiel - Levkovitz, M.D. PhD. Shalvata Mental Health Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Yechiel Levkovitz, M.D., Shalvata Mental Health Center Identifier: NCT00733057     History of Changes
Other Study ID Numbers: SMRI-GRANT-02T-244
Study First Received: August 11, 2008
Last Updated: August 11, 2008

Keywords provided by Shalvata Mental Health Center:
Negative symptoms

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017