Minocycline for the Treatment of Early-Phase Schizophrenia

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Negative and Cognitive Symptoms in Schizophrenia	Drug: Minocycline; Drug: Placebo (200 mg/day)	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	70 participants
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
Study Start Date :	August 2003
Actual Primary Completion Date :	March 2007
Actual Study Completion Date :	March 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Minocycline treatment	Drug: Minocycline; Minocycline as an add-on drug (200 mg/day)
Placebo Comparator: 2; Placebo	Drug: Placebo (200 mg/day)

Outcome Measures

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Primary Outcome Measures :

1. Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Change in SANS scores over the 6-month study ]

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Stanley Research Foundation (SMRI)- grants 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.

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 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