Status:
COMPLETED
Role of Minocycline in First Episode Psychosis
Lead Sponsor:
Stanley Medical Research Institute
Collaborating Sponsors:
Institute of Psychiatry, Rawalpindi Medical College, Pakistan
Pakistan Institute of Living and Learning
Conditions:
First Episode Psychosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 follow...
Detailed Description
Background: There is increasing clinical, neuropsychological and imaging evidence that schizophrenia involves a progressive process at the time of the first episode and later in life. However, it is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00916461
Start Date
May 1 2006
End Date
March 1 2008
Last Update
June 15 2009
Active Locations (4)
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1
Department of Neurology, Psychiatry and Psychological Medicine, University of San Paulo
São Paulo, Brazil
2
Civil Hospital Karachi
Karachi, Pakistan
3
Karwan e Hayat
Karachi, Pakistan
4
Institute of Psychiatry, Rawalpindi medical College
Rawalpindi, Pakistan