Clinical trial NCT01493622: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia minocycline cognition
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change from Baseline in the Composite Score From the Cognition Assessment Battery and SANS Total Scores After 16 Weeks of Treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment
timeFrame: 16 weeks
measure: Cytokine Measure
timeFrame: 16 weeks
measure: metabolic index
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Kunming
country: China
facility: Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College
state: Yunnan
Study officials:
affiliation: The Second Xiangya Hospital, Central South University,China
name: Zhao J Ping
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.