The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

NCT ID: NCT01493622

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Schizophrenia minocycline cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

variable dose SGA and 100mg per capsule po(take orally) bid,16 weeks;

minocycline

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

Group Type ACTIVE_COMPARATOR

minocycline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

minocycline

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

Intervention Type DRUG

placebo

variable dose SGA and 100mg per capsule po(take orally) bid,16 weeks;

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Minocycline Hydrochloride Capsules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central South University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fang Liu

Mental Health Institute of the Second Xiangya Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhao J Ping

Role: PRINCIPAL_INVESTIGATOR

The Second Xiangya Hospital, Central South University,China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Kunming, Yunnan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 19895780 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29526457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24503176 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010LL02

Identifier Type: OTHER

Identifier Source: secondary_id

CSU-2010-PSY

Identifier Type: -

Identifier Source: org_study_id