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Netherlands study of Optimal, PERsonalized Antidepressant use - OPERA discontinuation

Netherlands study of Optimal, PERsonalized Antidepressant use - OPERA discontinuation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25860
Enrollment
400
Registered
2020-04-22
Start date
2020-04-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Early discontinuation versus later discontinuation of antidepressants during the one year follow-up. Although the timing of discontinuation differs between both groups, similar discontinuation schem

Sponsors

ZonMW, grant number: 80-84800-98-40002
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Having a stable depression remission as confirmed by absence of a DSM-5 based diagnosis of major depressive disorder during the prior 6 months, as observed in the open-label treatment cohort (OPERA-monitor) from which participants are recruited 2. Use of sertraline (50, 100, 150 or 200 mg/day) or citalopram (10, 20, 30 or 40 mg/day) 3. 18-75 years at start of antidepressant medication

Exclusion criteria

Exclusion criteria: 1. Clinically overt primary psychiatric conditions other than depression that warrant different medical attention (i.e. earlier psychosis, schizophrenia, bipolar depression, alcohol or drug addiction) 2. Insufficient mastery of the Dutch language 3. Earlier inpatient admission for depression 4. History of >3 prior MDD episodes for which treatment was started 5. Overall treatment period with antidepressants for the last depressive episode lasted more than 18 months

Design outcomes

Secondary

MeasureTime frame
Secondary outcomes are functioning, quality of life, severity of mood, anxiety and somatic (e.g. side-effects and withdrawal) symptoms and (cost) effectiveness.

Primary

MeasureTime frame
Primary outcome is sustained remission time measured as time of follow-up without 1) severe depressive symptoms, 2) inpatient admission for depression, and 3) suicide (attempt).

Contacts

Public ContactMariska Bot

Amsterdam UMC, location VUmc, Psychiatry, Amsterdam, The Netherlands

opera@vumc.nl0207884594

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)