Overview
Sponsor-declared trial summary
Major Depressive Disorder
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.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 22 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511997-66-00
- EudraCT number
- 2021-006108-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
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.
Conditions and MedDRA coding
Major Depressive Disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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.
Exclusion criteria 4
- Psychotic or bipolar disorder
- Severe drug/alcohol addiction that warrants clinical attention
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rate of failure to successfully discontinue antidepressant: defined as significant deviation from discontinuation antidepressant protocol (e.g. switching to rescue medication (≥5 days in total), stopping with discontinuation medication) or significant withdrawal symptoms (increase in modified 15-item DESS from baseline ≥4 for ≥2 consecutive assessments) during Phase II.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP1113263 · ATC
- Active substance
- Venlafaxine
- Route of administration
- ORAL
- Max daily dose
- 375
- Max total dose
- 375
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX16 — VENLAFAXINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Dosages lower than marketing authorisation are applied, the product has been modified to resemble placebo
SCP129073 · ATC
- Active substance
- Paroxetine Hydrochloride
- Substance synonyms
- ANHYDROUS PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE ANHYDROUS, (3S,4R)-3-(BENZO[1,3]DIOXOL-5-YLOXYMETHYL)-4-(4-FLUOROPHENYL)PIPERIDINE HYDROCHLORIDE, PAROXETINE HCL
- Route of administration
- ORAL
- Max daily dose
- 50
- Max total dose
- 50
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AB05 — PAROXETINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Dosages lower than marketing authorisation are applied, the product has been modified to resemble placebo
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Christiaan Vinkers
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Christiaan Vinkers
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 200 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-11-22 | 2024-11-22 | 2025-12-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2024-511997-66-00 (Redact) | 1.13 |
| Recruitment arrangements (for publication) | 0_Transition Template | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.11 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Biobank information | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paroxetine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venlafaxine | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis in Dutch | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Netherlands | Acceptable 2024-11-22
|
2024-11-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-23 | Netherlands | Acceptable 2025-04-23
|
2025-04-24 |