EUCTR2020-002787-32-GB
Active, not recruiting
Phase 1
Antidepressant for the prevention of DEPression following first episode Psychosis trial - ADEPP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with First Episode Psychosis.
- Sponsor
- niversity of Birmingham
- Enrollment
- 508
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of first\-episode psychosis (FEP).
- •Within 3 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team).
- •Positive and Negative Syndrome Scale (PANSS) individual positive item scores all \= 4\.
- •Sufficiently recovered from acute psychotic episode with capacity to consent.
- •Aged 18\-35 years.
- •Currently prescribed antipsychotic medication at stable dose.
- •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 508
Exclusion Criteria
- •Current moderate or severe depression (as indicated by a Calgary Depression for
- •Schizophrenia Scale (CDSS) score of \>7\).
- •Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidaise Inhibitor)
- •Previous history of mania.
- •Contraindications to selective serotonin reuptake inhibitors (SSRI) antidepressant treatment (e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy, although risk in pregnancy is low, prescribed pimozide).
- •Serious medical or neurological illness (as identified by the treating consultant psychiatrist).
- •Electrocardiogram (ECG): QTc interval \>450 as measured in the last 12 months.
- •Aged below 18 years
- •Aged over 35 years
Outcomes
Primary Outcomes
Not specified
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