The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fang Liu, Central South University
ClinicalTrials.gov Identifier:
NCT01493622
First received: December 20, 2010
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: minocycline
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Central South University:

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 [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Cytokine Measure [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B

  • metabolic index [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    weight,height,insulin and waist circumference,


Enrollment: 78
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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;
Other Name: placebo
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 Name: Minocycline Hydrochloride Capsules

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493622

Locations
China, Yunnan
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
  More Information

Publications:
Responsible Party: Fang Liu, Mental Health Institute of the Second Xiangya Hospital, Central South University
ClinicalTrials.gov Identifier: NCT01493622     History of Changes
Other Study ID Numbers: CSU-2010-PSY, 2010LL02
Study First Received: December 20, 2010
Last Updated: December 14, 2011
Health Authority: China: Ethics Committee

Keywords provided by Central South University:
Schizophrenia minocycline cognition

Additional relevant MeSH terms:
Schizophrenia
Neurobehavioral Manifestations
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014