Antidepressant for the prevention of DEPression following first episode Psychosis trial

Phase 1

• Conditions: Patients with First Episode Psychosis.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-002787-32-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-16
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 508

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

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