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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 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| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733057
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:
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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017