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Clinical Trials/EUCTR2020-002787-32-GB
EUCTR2020-002787-32-GB
Active, not recruiting
Phase 1

Antidepressant for the prevention of DEPression following first episode Psychosis trial - ADEPP

niversity of Birmingham0 sites508 target enrollmentSeptember 16, 2020

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.

Registry
who.int
Start Date
September 16, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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