The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: placebo; Drug: minocycline

• Registration Number: NCT01493622
• Lead Sponsor: Central South University

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-12-20
• Primary Completion: 2011-11
• Status Verified: 2011-12
• Study Completion: 2011-12
• Study First Submitted QC: 2011-12-14
• Last Update Submitted: 2011-12-14
• Study First Posted: 2011-12-16
• Last Update Posted: 2011-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally.
minocycline	minocycline	Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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,

Trial Locations

Locations (1)

Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College; 🇨🇳 Kunming, Yunnan, China