Minocycline for the Treatment of Early-Phase Schizophrenia
This study has been completed.
Sponsor:
Shalvata Mental Health Center
Collaborator:
Abarbanel Mental Health Center
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00733057
First received: August 11, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PANSS, CGI, CDS, ITAQ, CANTAB measures, adverse events. [ Time Frame: Change during the 6-month duration of the study ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age between 18-35 years;
- current DSM-IV diagnosis of schizophrenia confirmed by the Structured Clinical Interview for DSM-IV (SCID) conducted by a trained psychiatrist.
- being at an early phase of the disorder (i.e., within five years of their first exposure to neuroleptic treatment;18)
- did not receive antipsychotic treatment for six months preceding current symptom exacerbation;
- baseline total score of more than 60 on the Positive and Negative Syndrome Scale (PANSS).
- 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);
- able to comprehend the procedure and aims of the study.
Exclusion Criteria:
- acute, unstable, significant or untreated medical illness beside schizophrenia;
- pregnant or breast-feeding females;
- A DSM-IV diagnosis of substance abuse or dependency;
- Known contraindication to minocycline treatment.
- Treatment with minocycline or Beta-lactam antibiotics in the preceding half year before study entry.
- Under compulsory hospitalization.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Shalvata Mental Health Center
Additional 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 |
| Study First Received: | August 11, 2008 |
| Last Updated: | August 11, 2008 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Shalvata Mental Health Center:
|
Minocycline Schizophrenia Negative symptoms Cognitive |
Additional relevant MeSH terms:
|
Schizophrenia Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Mental Disorders Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Minocycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013