Minocycline Augmentation in Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Minocycline Augmentation in Early-Course Schizophrenia|
- Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, week 8, and week 16 of the study ] [ Designated as safety issue: No ]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.
- Treatment-induced change in MATRICS Cognitive Consensus Battery (MCCB) [ Time Frame: Baseline and week 16 of the study ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Cytokine levels will assessed at baseline and week 16 of the study to examine treatment-induced changes in neuroinflammation.
|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)|
Minocycline will be given orally at 200 mg a day for 4 months
Other Name: Minocin
|Placebo Comparator: Placebo||
EquivalentPlacebo will be given
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561742
|Contact: Johanna E Gerwer, BSemail@example.com|
|Contact: Wilmer J Burns, MSfirstname.lastname@example.org|
|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.|
|Principal Investigator:||Mujeeb U Shad, MD, MSCS||UT Health Sciences Center at Houston|