The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

NCT01493622 | Completed Phase 4 DMC

• 2 other identifiers: CSU-2010-PSY2010LL02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia minocycline cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Change from Baseline in the PANSS and PSP Total Scores after 16 weeks Treatment

  16 weeks

• Cytokine Measure

  16 weeks

• metabolic index

  16 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: placebo

minocycline

ACTIVE COMPARATOR

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

Drug: minocycline

Interventions

minocycline DRUG

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

Also known as: Minocycline Hydrochloride Capsules

minocycline

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

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

Kunming, Yunnan, 650031, China

Location

Related Publications (3)

• 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.

  PMID: 19895780 RESULT

• 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.

  PMID: 29526457 DERIVED

• 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.

  PMID: 24503176 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Zhao J Ping

  The Second Xiangya Hospital, Central South University,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mental Health Institute of the Second Xiangya Hospital

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 16, 2011
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

CN (1)