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Minocycline for the Treatment of Early-Phase Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733057
First Posted: August 12, 2008
Last Update Posted: August 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abarbanel Mental Health Center
Information provided by:
Shalvata Mental Health Center
  Purpose
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
Placebo
Drug: Placebo (200 mg/day)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733057


Locations
Israel
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
Investigators
Principal Investigator: Yechiel - Levkovitz, M.D. PhD. Shalvata Mental Health Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Yechiel Levkovitz, M.D., Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00733057     History of Changes
Other Study ID Numbers: SMRI-GRANT-02T-244
First Submitted: August 11, 2008
First Posted: August 12, 2008
Last Update Posted: August 12, 2008
Last Verified: August 2008

Keywords provided by Shalvata Mental Health Center:
Minocycline
Schizophrenia
Negative symptoms
Cognitive

Additional relevant MeSH terms:
Schizophrenia
Neurobehavioral Manifestations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents