The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

December 14, 2011 updated by: Fang Liu, Central South University

A Double-Blind,Randomized Study of Minocycline for the Treatment of 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650031
        • Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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:
  • 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
Time Frame: 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
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
Time Frame: 16 weeks
16 weeks
Cytokine Measure
Time Frame: 16 weeks
Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B
16 weeks
metabolic index
Time Frame: 16 weeks
weight,height,insulin and waist circumference,
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: Zhao J Ping, The Second Xiangya Hospital, Central South University,China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 14, 2011

First Posted (ESTIMATE)

December 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU-2010-PSY
  • 2010LL02 (OTHER: The First Affiliated Hospital of Kunming Medical College)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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