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Sponsors and Collaborators: |
Shalvata Mental Health Center Abarbanel Mental Health Center, Bat-Yam, Israel. |
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Information provided by: | Shalvata Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00733057 |
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 |
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Negative and Cognitive Symptoms in Schizophrenia |
Drug: Minocycline Drug: Placebo (200 mg/day) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Early-Phase Schizophrenia |
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 |
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1: Experimental
Minocycline treatment
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Drug: Minocycline
Minocycline as an add-on drug (200 mg/day)
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2: Placebo Comparator
Placebo
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Drug: Placebo (200 mg/day) |
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
The Emotion-Cognition Research Center, The Shalvata Mental Health Care Center, P.O.B. 94. | |
Hod-Hasharon, Israel, 70300 |
Principal Investigator: | Yechiel - Levkovitz, M.D. PhD. | Shalvata Mental Health Center |
Responsible Party: | Shalvata Mental Health Center ( Dr. Yechiel Levkovitz, M.D. ) |
Study ID Numbers: | SMRI-GRANT-02T-244 |
Study First Received: | August 11, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00733057 History of Changes |
Health Authority: | Israel: Ministry of Health |
Minocycline Schizophrenia Negative symptoms Cognitive |
Schizophrenia Anti-Bacterial Agents Signs and Symptoms Minocycline Mental Disorders |
Neurologic Manifestations Psychotic Disorders Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Anti-Infective Agents Anti-Bacterial Agents Signs and Symptoms Minocycline Mental Disorders |
Therapeutic Uses Nervous System Diseases Neurologic Manifestations Neurobehavioral Manifestations Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |