COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Minocycline for the Treatment of Early-Phase Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733057
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
Abarbanel Mental Health Center
Information provided by:
Shalvata Mental Health Center

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

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

Placebo Comparator: 2
Drug: Placebo (200 mg/day)

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733057

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Yechiel - Levkovitz, M.D. PhD. Shalvata Mental Health Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Yechiel Levkovitz, M.D., Shalvata Mental Health Center Identifier: NCT00733057    
Other Study ID Numbers: SMRI-GRANT-02T-244
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 12, 2008
Last Verified: August 2008
Keywords provided by Shalvata Mental Health Center:
Negative symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurobehavioral Manifestations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents