The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia|
- Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]The Cognitive Assessment Battery included Making Test (TMT) ,Symbol Coding,Hopkins Verbal Learning Test-Revised ,Mazes,Brief Visuospatial Memory Test-Revised ,Continuous Performance Test-Identical Pairs,Grooved Pegboard Test,Color Trail Test,Stroop Task,Verbal Fluency,Paced Auditory Serial Addition Test and Wisconsin Card Sorting Test SANS=Scale for the Assessment of Negative Symptoms
- Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Cytokine Measure [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B
- metabolic index [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]weight,height,insulin and waist circumference,
|Study Start Date:||June 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally.
variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；
Other Name: placebo
Active Comparator: minocycline
Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally.
variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；
Other Name: Minocycline Hydrochloride Capsules
Immune-related disorders have been hypothesized as etiological factors in schizophrenia.Minocycline is a second-generation tetracycline that exerts anti-inflammatory and antimicrobial effects while having a distinct neuroprotective profile.This study was performed as a double-blind, placebocontrolled,randomized evaluation of Second generation antipsychotics(SGA) and minocycline versus SGA and placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493622
|Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College|
|Kunming, Yunnan, China, 650031|
|Principal Investigator:||Zhao J Ping||The Second Xiangya Hospital, Central South University,China|