Role of Minocycline in First Episode Psychosis

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanley Medical Research Institute
• Collaborators: Pakistan Institute of Learning and Living; Pakistan Institute of Living and Learning; Rawalpindi Medical College, Pakistan; University of Sao Paulo
• Treatments: Minocycline

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