Minocycline Augmentation in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01561742|
Recruitment Status : Unknown
Verified March 2012 by Mujeeb Shad, The University of Texas Health Science Center, Houston.
Recruitment status was: Recruiting
First Posted : March 23, 2012
Last Update Posted : March 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Minocycline Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Minocycline Augmentation in Early-Course Schizophrenia|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
Minocycline will be given orally at 200 mg a day for 4 months
Other Name: Minocin
|Placebo Comparator: Placebo||
EquivalentPlacebo will be given
- 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.
- 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.
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
|Contact: Johanna E Gerwer, BSfirstname.lastname@example.org|
|Contact: Wilmer J Burns, MSemail@example.com|
|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|