Minocycline for the Treatment of Early-Phase Schizophrenia

This study has been completed.
Sponsor:
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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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:
Neurobehavioral Manifestations
Schizophrenia
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014