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The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

C

Central South University

Status and phase

Completed
Phase 4

Conditions

Schizophrenia

Treatments

Drug: minocycline
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01493622
2010LL02 (Other Identifier)
CSU-2010-PSY

Details and patient eligibility

About

The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.

Full 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.

Enrollment

78 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

78 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally.
Treatment:
Drug: placebo
minocycline
Active Comparator group
Description:
Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally.
Treatment:
Drug: minocycline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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