EUCTR2021-006108-34-NL
Active, not recruiting
Phase 1
Trial Examining Methods for Antidepressant Discontinuation - TEMPO
AmsterdamUMC (location VUmc)0 sites200 target enrollmentAugust 13, 2022
ConditionsMajor Depressive DisorderMedDRA version: 21.1Level: LLTClassification code 10025464Term: Major depressive disorder, single episode in full remissionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 21.1Level: LLTClassification code 10025455Term: Major depressive disorder, recurrent episode, in full remissionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: LLTClassification code 10025465Term: Major depressive disorder, single episode, in partial or unspecified remissionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: LLTClassification code 10025456Term: Major depressive disorder, recurrent episode, in partial or unspecified remissionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- AmsterdamUMC (location VUmc)
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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