The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: placebo; Drug: minocycline

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650031
      • Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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；
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 Names: Minocycline Hydrochloride Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment		16 weeks
Cytokine Measure	Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B	16 weeks
metabolic index	weight,height,insulin and waist circumference,	16 weeks

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Principal Investigator: Zhao J Ping, The Second Xiangya Hospital, Central South University,China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (ESTIMATE): December 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Schizophrenia minocycline cognition
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Neurobehavioral Manifestations; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: CSU-2010-PSY; 2010LL02 (OTHER: The First Affiliated Hospital of Kunming Medical College)