Trial Examining Methods for Antidepressant Discontinuatio

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 21.1Level: LLTClassification code 10025464Term: Major depressive disorder, single episode in full remissionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: LLTClassification code 10025455Term: Major depressive disorder, recurrent episode, in full remissionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: LLTClassification code 10025465Term: Major depressive disorder, single episode, in partial or unspecified remissionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: LLTClassification code 10025456Term: Major depressive disorder, recurrent episode, in partial or unspecified remissionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-006108-34-NL
• Lead Sponsor: AmsterdamUMC (location VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-13
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all of the following criteria:
•Age 18-75 years
•Stable 6-month remission of MDD
•Confirmed >6 months use of PAR (20-50mg) or VLX (75-375mg)
•Previous MDD episode and current remission confirmed with semi-structured psychiatric interview (MINI).
•Willing and able to provide informed consent and follow the procedures necessary to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Psychotic/bipolar disorder
•Severe drug/alcohol addiction that warrants clinical attention
•Insufficient mastery of Dutch language.

Study & Design

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