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Role of Minocycline in First Episode Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916461
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : June 15, 2009
Rawalpindi Medical College, Pakistan
Pakistan Institute of Living and Learning
University of Sao Paulo
Information provided by:
Stanley Medical Research Institute

Brief Summary:

The purpose of this study is to determine whether the addition of minocycline or placebo to treatment as usual (TAU):

  1. prevents the accumulation of negative symptoms and intellectual decline following a first episode of non-affective psychosis; and
  2. whether minocycline stabilizes the efficacy of antipsychotics.

Condition or disease Intervention/treatment Phase
First Episode Psychosis Drug: Minocycline Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind Pilot Study of Minocycline and Placebo Added to Treatment-as-Usual (TAU) in First-Episode Psychosis
Study Start Date : May 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Minocycline Drug: Minocycline
Minocycline + treatment as usual. 50 mg twice daily increasing to 200 mgs per day, increments of 50 mgs every 2 weeks.

Placebo Comparator: Sugar Pill Drug: Placebo
Placebo + treatment as usual.

Primary Outcome Measures :
  1. Positive and negative symptoms on Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) [ Time Frame: Baseline and 12 months ]
  2. Global Assessment of Functioning (GAF) [ Time Frame: Baseline and 12 months ]
  3. Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and 12 months ]
  4. Assessment of side effects [ Time Frame: Baseline and 12 months ]
  5. Doses of antipsychotic drugs [ Time Frame: Baseline and 12 months ]
  6. neurocognitive test scores [ Time Frame: Baseline and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 18 to 65 years
  • Diagnostic and Statistical Manual-IV (DSM-IV) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
  • First episode (within first 5 years of diagnosis)
  • Competent and willing to give informed consent
  • Medication remained stable 4 weeks prior to baseline
  • Able to take oral medication and likely to complete the required evaluations
  • Female participants of child bearing capability must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre-treatment and at ten weekly intervals while on study medication

Exclusion Criteria:

  • Relevant medical illness [renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosus (SLE)] in the opinion of the investigators (see section 6.2a)
  • Prior history of intolerance to any of the tetracyclines
  • Concomitant penicillin therapy
  • Concomitant anticoagulant therapy
  • Presence of a seizure disorder, not including clozapine-induced seizures
  • Presently taking valproic acid
  • Any change of psychotropic medications within the previous six weeks
  • Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria
  • Pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916461

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Department of Neurology, Psychiatry and Psychological Medicine, University of San Paulo
San Paulo, Brazil
Civil Hospital Karachi
Karachi, Pakistan
Karwan e Hayat
Karachi, Pakistan
Institute of Psychiatry, Rawalpindi medical College
Rawalpindi, Pakistan
Sponsors and Collaborators
Stanley Medical Research Institute
Rawalpindi Medical College, Pakistan
Pakistan Institute of Living and Learning
University of Sao Paulo
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Principal Investigator: Imran B Chaudhry, MD University of Manchester
Study Director: Jaime EC Hallak, MD University of San Paulo, Brazil
Study Director: Nusrat Husain, MD University of Manchester

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Responsible Party: Dr Imran B Chaudhry, University of Manchester Identifier: NCT00916461    
Other Study ID Numbers: SMRI 04T-583
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 2009
Keywords provided by Stanley Medical Research Institute:
First episode psychosis
First episode non affective psychosis
With in first five years of illness
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Anti-Bacterial Agents
Anti-Infective Agents