The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally. |
Drug: placebo
variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；
|
| Active Comparator: minocycline Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally. |
Drug: minocycline
variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment [16 weeks]
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
Secondary Outcome Measures
- Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment [16 weeks]
- Cytokine Measure [16 weeks]
Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B
- metabolic index [16 weeks]
weight,height,insulin and waist circumference,
Eligibility Criteria
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;
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College | Kunming | Yunnan | China | 650031 |
Sponsors and Collaborators
- Central South University
Investigators
- Principal Investigator: Zhao J Ping, The Second Xiangya Hospital, Central South University,China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSU-2010-PSY
- 2010LL02