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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
History of Changes
  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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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 May 19, 2013