Interventional, randomised, open label, multi-centre, parallel-group, controlled study investigating the effects of using the PReDicT test to guide the antidepressant treatment of depressed patients

Completed

• Conditions: depression; mood disorder; 10027946

• Registration Number: NL-OMON47147
• Lead Sponsor: P1vital Products Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- Male or female and aged between 18 and 65 inclusive.
- Diagnosed with a depressive episode by a physician (either first episode or
recurrent) and requiring treatment with a selective serotonin reuptake
inhibitor (SSRI) medication (excluding fluoxetine).
- Prescribed an SSRI by a physician for the treatment of depression within
the 7 days prior to Visit 1, but has not yet started taking the medication.
- Is intending to start SSRI treatment within 7 days of Visit 1.

Exclusion Criteria

- Previous history of mania.
- Is currently taking an antidepressant medication or has stopped
antidepressant treatment within 2 weeks prior to Visit 1. Participants who are taking or have taken antidepressant medication for treatment of a different condition at a dose which does not have an antidepressant effect are eligible for inclusion.
- Requires immediate referral to alternative mental health services (e.g.
where patient seen in primary care is referred to secondary care services).
- Presents to a physician with significant current suicidal intent requiring
enhanced care.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br>* Change in QIDS-SR-16 score from week 0 (baseline) to week 8. [Quick Inventory<br /><br>of Depressive Symptomology - Self Report]</p><br>