Depression
Conditions
Interventions
Trade Name: Sertraline
Product Name: Sertraline
Product Code: n/a
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: C
Sponsors
VU Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Having a stable depression remission as evidenced by reporting an IDS score =21 (i.e. no moderate or severe depressive symptoms) during two consecutive bimonthly assessments and a confirmed absence of a DSM-5 diagnosis of MDD during 6 months, as observed in the OPERA-MONITOR study. • Use of sertraline (50, 100, 150 or 200 mg/day) or citalopram (10, 20, 30 or 40 mg/day). • Willing to be randomized and provide written informed consent. 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 320 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Earlier inpatient admission for depression. • History of >3 prior episodes for which treatment was started. • Overall treatment period with antidepressant for the last depressive episode did last more than 18 months (chronic patients are excluded: in this difficult-to-treat group continuation of antidepressants is recommended as a-priori relapse risk is known to be high). • Presence of other clinically overt primary psychiatric conditions that warrant different medical attention (earlier confirmed psychosis, schizophrenia or bipolar depression for which medical care has been provided, or alcohol or drug addiction which is currently treated). • Insufficient mastery of Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine in depressed patients who reach a 6-month stable depression remission during optimal AD treatment: 1) whether discontinuation is possible; 2) when discontinuation is possible; and 3) in whom discontinuation is possible.;Secondary Objective: To conduct a cost-effectiveness analysis;Timepoint(s) of evaluation of this end point: At 7, 14, 21, 28, 35, 42, 49, 56, 80 and 104 weeks after baseline assessment.;Primary end point(s): Primary outcome involves sustained remission time measured as time of follow-up without severe depressive symptoms, inpatient admission for depression and suicide (attempt). Severe depressive symptoms are defined as having an IDS score>25 (moderately/severely depressed) and meeting DSM-5 criteria for MDD for 2 weeks according the psychiatric MINI interview. Suicide attempt is assessed using suicide IDS and MINI items followed up with the suicide behaviour question of the Columbia Suicide Severity Rating Scale (C-SSRS) Screen Version) and should be confirmed by two OPERA-researchers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life, functioning, severity of psychiatric and somatic symptoms (e.g. side effects, withdrawal symptoms).;Timepoint(s) of evaluation of this end point: At 7, 14, 21, 28, 35, 42, 49, 56, 80 and 104 weeks after baseline assessment (differs per outcome). | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Psychiatry
VU Medical Center
Outcome results
None listed