MedPath

RADAR Trial

Phase 1
Conditions
Schizophrenia, delusional disorders, schizoaffective disorder, psychosis
MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 20.0Level: HLTClassification code 10012256Term: Delusional disordersSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 20.0Level: PTClassification code 10039621Term: Schizoaffective disorderSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 20.0Level: LLTClassification code 10037234Term: PsychosisSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Registration Number
EUCTR2016-000709-36-GB
Lead Sponsor
C
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
402
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath