The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.

Detailed Description
-----------------
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.

Official Title
-----------------
A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: minocycline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female,were aged 18-40 years were currently diagnosed with DSM-IV schizophrenia were able to comprehend the cognition test patients or guardian signed informed consent,were able to comprehend the procedure and aims of the study,agreed to join the study patient's current antipsychotic medication regimen must be stable must be in a stable living arrangement Exclusion Criteria: had ever been hypersensitivity to minocycline or tetracycline; had acute,unstable,significant,or untreated medical illness besides schizophrenia were pregnant or breast-feeding; had a DSM-IV diagnosis of substance abuse or dependency; had a tendency to suicide or Violence,self-harm; had taken immunosuppressive agents in the preceding 3 months before study entry; had influenza or fever in the preceding 2 weeks before study entry; had a DSM-IV diagnosis of emotional psychosis,Mental retardation,etc. has suicidal attempts or ideation or violent behavior within the last 12 months patient has mental retardation or severe organic brain syndromes treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally. | Drug: placebo<br>* variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；<br>|
| Active Comparator: minocycline<br>Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally. | Drug: minocycline<br>* variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；<br>* Other names: Minocycline Hydrochloride Capsules;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment | 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 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment |  | 16 weeks | 
| Cytokine Measure | Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B | 16 weeks | 
| metabolic index | weight,height,insulin and waist circumference, | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia minocycline cognition