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The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
minocycline
placebo
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia minocycline cognition

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

minocycline

Arm Description

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

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

Outcomes

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
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
Cytokine Measure
Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B
metabolic index
weight,height,insulin and waist circumference,

Full Information

First Posted
December 20, 2010
Last Updated
December 14, 2011
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT01493622
Brief Title
The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia
Official Title
A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia minocycline cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be given with 200mg/day placebo(100mg,bid) and variable dose SGA. All drugs will be administered orally.
Arm Title
minocycline
Arm Type
Active Comparator
Arm Description
Subjects will be given with 200mg/day minocycline (100mg,bid)and variable dose SGA.All drugs will be administered orally.
Intervention Type
Drug
Intervention Name(s)
minocycline
Other Intervention Name(s)
Minocycline Hydrochloride Capsules
Intervention Description
variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；
Primary Outcome Measure Information:
Title
Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment
Time Frame
16 weeks
Title
Cytokine Measure
Description
Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B
Time Frame
16 weeks
Title
metabolic index
Description
weight,height,insulin and waist circumference,
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao J Ping
Organizational Affiliation
The Second Xiangya Hospital, Central South University,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650031
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19895780
Citation
Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.
Results Reference
result
PubMed Identifier
29526457
Citation
Liu F, Zhang B, Xie L, Ruan Y, Xu X, Zeng Y, Messina L, Zhao J, Fan X. Changes in plasma levels of nitric oxide metabolites and negative symptoms after 16-week minocycline treatment in patients with schizophrenia. Schizophr Res. 2018 Sep;199:390-394. doi: 10.1016/j.schres.2018.03.003. Epub 2018 Mar 9.
Results Reference
derived
PubMed Identifier
24503176
Citation
Liu F, Guo X, Wu R, Ou J, Zheng Y, Zhang B, Xie L, Zhang L, Yang L, Yang S, Yang J, Ruan Y, Zeng Y, Xu X, Zhao J. Minocycline supplementation for treatment of negative symptoms in early-phase schizophrenia: a double blind, randomized, controlled trial. Schizophr Res. 2014 Mar;153(1-3):169-76. doi: 10.1016/j.schres.2014.01.011. Epub 2014 Feb 3.
Results Reference
derived

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The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

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