2024-511997-66-00Active, not recruitingPhase 4
Trial Examining Methods for Antidepressant Discontinuation (TEMPO)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Apr 2025
Brief summary (registry, in English)
TEMPO is a double-blind placebo-controlled RCT which aims to investigate how antidepressants should best be discontinued. To this end, TEMPO will compare two tapering strategies in patients with stable remitted MDD who use either PAR or VLX.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- 22 Nov 2024
- Lead sponsor
- Amsterdam UMC Stichting
- Diseases
- Depression
- EU CT number
- 2024-511997-66-00
- EudraCT number
- 2021-006108-34
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe drug/alcohol addiction that warrants clinical attention
Other illness
- Psychotic or bipolar disorder
Other
- Use of other antidepressants (starting at the minimally effective dose), augmentation treatment (e.g. aripiprazole, olanzapine, lithium) and/or chronic high doses of benzodiazepines (daily use of >10mg diazepam equivalent)
- Insufficient mastery of Dutch language.
Who the study is looking for
- Age 18-75 years
- Stable ≥6-month (≥1 year in recurrent MDD) remission of MDD, confirmed with a score of 12 or lower on the Patient Health Questionnaire 9 (PHQ-9)
- Use of paroxetine (20-50mg) or venlafaxine (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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Active, not recruiting |
| Radboud Universitair Medisch Centrum (Radboudumc) | Nijmegen | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.