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Minocycline Augmentation in Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Mujeeb Shad, The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561742
First Posted: March 23, 2012
Last Update Posted: March 23, 2012
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.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mujeeb Shad, The University of Texas Health Science Center, Houston
  Purpose
This study aims to examine the efficacy of minocycline augmentation in a sample of moderately ill outpatients with early-course schizophrenia on their chlorpromazine-equivalent doses of second-generation antipsychotic medications. The investigators hypothesize that as compared to placebo a 2-month treatment with minocycline in 120 volunteers with early-course schizophrenia will result in a more significant improvement in psychopathology (primary outcome) and cognitive symptoms (secondary outcome). In addition, cytokine plasma levels will be used as another secondary outcome measure to see if treatment-induced changes in total PANSS score are associated with changes in cytokine levels.

Condition Intervention
Schizophrenia Drug: Minocycline Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Minocycline Augmentation in Early-Course Schizophrenia

Resource links provided by NLM:


Further study details as provided by Mujeeb Shad, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, week 8, and week 16 of the study ]
    PANSS total score will be used to examine treatment-induced change in psychaopthology. The PANSS is a 30-item rating scale used to assess symptoms of psychopathology. We will use the total PANSS score as the primary outcome measure which reflects total level of psychopathology including the positive and negative symptoms as well as general psychopathology.This measure will be administered at baseline, week 8 and week 16 of the study to assess if minocyline treatment results in a significant reduction in PANSS total score as opposed to placebo.


Secondary Outcome Measures:
  • Treatment-induced change in MATRICS Cognitive Consensus Battery (MCCB) [ Time Frame: Baseline and week 16 of the study ]
    Average total score on MCCB will be used to examine treatment-induced change in cognitive function. MCCB (Nuechterlein et al., 2008) will be admisnitered at the baseline an week 16 of the study. The MCCB assesses 7 domains of cognitive functioning known to be impaired for individuals with schizophrenia. A summary score averaging across domains is generated as a global measure of cognitive functioning.

  • Treatment-induced changes in plasma level of cytokines [ Time Frame: Baseline and week 16 of the study ]
    Cytokine levels will assessed at baseline and week 16 of the study to examine treatment-induced changes in neuroinflammation.


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline Drug: Minocycline
Minocycline will be given orally at 200 mg a day for 4 months
Other Name: Minocin
Placebo Comparator: Placebo Drug: Placebo
EquivalentPlacebo will be given

Detailed Description:
Minocycline, which is a second-generation tetracycline, has been found to inhibit Nitric Oxide Synthase (NOS) and inflammatory cytokines. These are some of the primary mechanisms that have been proposed to explain its neuroprotective and neuroplastic effects in several animal and human models of neurological and psychiatric diseases, including Parkinson's disease and schizophrenia. There are only three clinical trials with minocycline in schizophrenia subjects. A more definitive clinical trial in a larger sample with optimized and cost-effective design using a comprehensive cognitive battery and a global assessment of schizophrenia symptom domains is necessary to examine the efficacy of minocycline. If minocycline improves psychopathology and potentially other symptoms (including cognitive function) for schizophrenia, the treatment could be easily implemented in the existing treatment delivery system at relatively low cost and have the potential for making a significant public health impact. The investigators plan to recruit 120 individuals with early course schizophrenia who are currently on second-generation antipsychotic (SGA) medications and are experiencing persistent symptoms in at least the moderate range. In an effort to limit placebo response, which is notoriously high in psychiatric population, the investigators are using an adaptive design. Since, there is growing evidence to support the inflammatory hypothesis of schizophrenia, the investigators will also explore whether cytokine levels mediate the response from minocycline treatment.
  Eligibility

Information from the National Library of Medicine

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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. Ages between 18-35 years
  2. Males & females
  3. Current DSM-IV diagnosis of schizophrenia or schizoaffective disorder confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) conducted by a trained psychiatrist.
  4. Treatment with a stable dose of second generation antipsychotic medication for at least 1 months prior to study entry 200-600 mg/day chlorpromazine equivalent doses);
  5. Evidence of stable symptomatology for 12 weeks as evidenced by no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms, no ER use for symptoms of schizophrenia and no significant changes to antipsychotic medication or dose (>25%) in the past 12 weeks.
  6. Baseline total score between 40 and 65 on the Brief Psychiatric Rating Scale (BPRS);
  7. Raw score of 12 or higher on the Wechsler Test of Adult Reading (WTAR) (estimates premorbid IQ).
  8. Able to comprehend the procedure and aims of the study to provide informed consent

Exclusion Criteria:

  1. Acute, unstable, significant or untreated medical illness beside schizophrenia;
  2. Pregnant or breast-feeding females;
  3. History of substance abuse or dependence in the past 3 months.
  4. Known contraindication to minocycline treatment.
  5. Treatment with minocycline or Beta-lactam antibiotics in the preceding half year before study entry.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01561742


Contacts
Contact: Johanna E Gerwer, BS 7134862574 johanna.e.gerwer@uth.tmc.edu
Contact: Wilmer J Burns, MS 7134862574 wilmer.j.burns@uth.tmc.edu

Locations
United States, Texas
Harris County Psychiatric Center Recruiting
Houston, Texas, United States, 77021
Contact: Nina Herring, RN, BSN    713-741-4820    Nina.G.Herring@uth.tmc.edu   
Sub-Investigator: Adel Wasseff, M.D.         
Principal Investigator: Mujeeb U Shad, M.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Stanley Medical Research Institute
Investigators
Principal Investigator: Mujeeb U Shad, MD, MSCS UT Health Sciences Center at Houston
  More Information

Responsible Party: Mujeeb Shad, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01561742     History of Changes
Other Study ID Numbers: HSC-MS-11-0201
First Submitted: March 14, 2012
First Posted: March 23, 2012
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by Mujeeb Shad, The University of Texas Health Science Center, Houston:
minocycline, augmentation, schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents