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CompletedNCT01493622Updated Dec 16, 2011

The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

A Phase 4 interventional study of minocycline and placebo in Schizophrenia, sponsored by Central South University. Completed at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-16.

Sponsored by Central South University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia minocycline cognition
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In context

Neurobehavioral Manifestations

111 studies on the registry are indexed under Neurobehavioral Manifestations; 28 are open to participants now.

This study's enrollment of 78 is close to the median of 71 across 84 interventional studies indexed under Neurobehavioral Manifestations.

Browse Neurobehavioral Manifestations studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Drugminocycline

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

    Also known as: Minocycline Hydrochloride Capsules

  • Drugplacebo

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

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What researchers measure

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

    Time frame: 16 weeks

Secondary outcomes

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

    Time frame: 16 weeks

  2. Cytokine Measure

    Cytokine Measure:IL-1β,IL-6,TNF-α,Nitric Oxide (NO)、S100B

    Time frame: 16 weeks

  3. metabolic index

    weight,height,insulin and waist circumference,

    Time frame: 16 weeks

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Study locations

1 site
  • Department of Psychiatry, The First Affiliated Hospital of Kunming Medical College
    Kunming, Yunnan 650031, China
08

References and documents

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. PubMed 19895780 ↗
  • 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. PubMed 29526457 ↗
  • 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. PubMed 24503176 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01493622
Lead sponsor
Central South University
Responsible party
Fang Liu (Mental Health Institute of the Second Xiangya Hospital, Central South University) — Principal investigator
First posted
Dec 16, 2011
Start date
Jun 2010
Primary completion
Nov 2011
Completion
Dec 2011
Last update
Dec 16, 2011

Study contacts

Zhao J Ping
principal investigator · The Second Xiangya Hospital, Central South University,China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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