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Role of Minocycline in First Episode Psychosis

This study has been completed.
Sponsor:
Collaborators:
Rawalpindi Medical College, Pakistan
Pakistan Institute of Learning and Living, Pakistan
University of Sao Paulo
Information provided by:
Stanley Medical Research Institute
ClinicalTrials.gov Identifier:
NCT00916461
First received: June 8, 2009
Last updated: June 12, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
First Episode Psychosis
 Drug: Minocycline
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanley Medical Research Institute:

Primary Outcome Measures:
  • Positive and negative symptoms on Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (GAF) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Assessment of side effects [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Doses of antipsychotic drugs [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • neurocognitive test scores [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: May 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916461

Locations
Brazil
Department of Neurology, Psychiatry and Psychological Medicine, University of San Paulo
San Paulo, Brazil
Pakistan
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 Learning and Living, Pakistan
University of Sao Paulo
Investigators
Principal Investigator: Imran B Chaudhry, MD University of Manchester, UK
Study Director: Jaime EC Hallak, MD University of San Paulo, Brazil
Study Director: Nusrat Husain, MD University of Manchester, UK
  More Information

Publications:

Responsible Party: Dr Imran B Chaudhry, University of Manchester
ClinicalTrials.gov Identifier: NCT00916461     History of Changes
Other Study ID Numbers: SMRI 04T-583
Study First Received: June 8, 2009
Last Updated: June 12, 2009
Health Authority: Brazil: National Committee of Ethics in Research
Pakistan: Research Ethics Committee

Keywords provided by Stanley Medical Research Institute:
First episode psychosis
Schizophrenia
Minocycline
 neuroprotection
First episode non affective psychosis
With in first five years of illness

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Minocycline
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013