The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Double-Blind,Randomized Study of Minocycline for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493622
• Other study ID #: CSU-2010-PSY
• Secondary ID: 2010LL02
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2010
• Last updated: December 14, 2011
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurobehavioral Manifestations
• Schizophrenia

Intervention

Drug:
• minocycline
variable dose SGA and minocycline,100mg per capsule po(take orally) bid,16 weeks;
• placebo
variable dose SGA and 100mg per capsule po(take orally) bid,16 weeks;

Locations

Country	Name	City	State
China	Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 weeks	Yes
Secondary	Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment		16 weeks	Yes
Secondary	Cytokine Measure	Cytokine Measure:IL-1ß,IL-6,TNF-a,Nitric Oxide (NO)?S100B	16 weeks	Yes
Secondary	metabolic index	weight,height,insulin and waist circumference,	16 weeks	Yes