EUCTR2016-000709-36-GB
Active, not recruiting
Phase 1
Research into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial - RADAR Trial
ConditionsSchizophrenia, delusional disorders, schizoaffective disorder, psychosisMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: HLTClassification code 10012256Term: Delusional disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: PTClassification code 10039621Term: Schizoaffective disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: LLTClassification code 10037234Term: PsychosisSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Schizophrenia, delusional disorders, schizoaffective disorder, psychosis
- Sponsor
- C
- Enrollment
- 402
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Aged over 18 years
- •2\.A clinical and/or ICD10 diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other non\-affective psychosis
- •3\.More than one previous episode of relapse or psychotic exacerbation, or a single episode lasting more than one year
- •4\.Taking antipsychotic medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 302
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 100
Exclusion Criteria
- •1\.Participant lacks capacity to consent to the trial
- •2\.Participant has insufficient command of spoken English to understand trial procedures
- •3\.Participant subject to a Community Treatment Order (CTO) that includes a requirement to take antipsychotic medication
- •4\.Clinician considers there will be a serious risk of harm to self or others
- •5\.Participant has been admitted to hospital or had treatment from the Home Treatment or Crisis Team within the last month
- •6\.Females who have a confirmed pregnancy
- •7\.Females who are breast\-feeding
- •8\.Involvement in another IMP trial
- •9\.No contraindications to continuing on antipsychotic medication
Outcomes
Primary Outcomes
Not specified
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