Optimization of Treatment and Management of Schizophrenia in Europe - OPTiMiSE

Phase 1

• Conditions: Schizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1; MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia; MedDRA version: 12.1Level: LLTClassification code 10039647Term: Schizophreniform disorder

• Registration Number: EUCTR2010-020185-19-GB
• Lead Sponsor: niversity Medical Centre Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-06
• Study Completion: 2017-11-01
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

i) Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder, as defined by DSM-IV on the basis of the Mini International Neuropsychiatric Interview Plus (M.I.N.I. Plus; Sheehan et al. 1998), a short diagnostic structured interview.
ii) Age 18-40 years
iii) Written informed consent
iv) Mental capacity to understand and consent to the study (as determined using attached mental capacity assessment form).

For all participants at UK site:
iii) Adequate command of English to understand the study and complete the assessments
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i) A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
ii) Prior use of antipsychotic medication for longer than an episode of two weeks in the previous year and/or 6 weeks during lifetime.
iii) Intolerance to one of the drugs in this study.
iv) The presence of one or more of the contraindications against any of the study drugs
vi) Pregnancy, as determined through a pregnancy test, or lactation
vii) Lack of mental capacity to understand and consent to the study (as determined using attached mental capacity assessment form).

For participation in MRI scans only (if they meet this exclusion criteria, they can still participate in the rest of the study)
i) any contraindication to imaging e.g. implanted metallic objects or electronic devices

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified