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Disrupting the rythm of depression: effectiveness and cost-effectiveness and mediating factors of preventive cognitive therapy, with or without antidepressants and compared to antidepressants alone, in the prevention of recurrent major depressive disorder.

Disrupting the rythm of depression: effectiveness and cost-effectiveness and mediating factors of preventive cognitive therapy, with or without antidepressants and compared to antidepressants alone, in the prevention of recurrent major depressive disorder. - Disrupting the rhythm of depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39379
Enrollment
276
Registered
2009-04-28
Start date
2009-06-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

major depressive disorder melancholia

Interventions

In the treatment arm where AD will be continued GP*s and psychiatrists will be advised to prescribe continuation/maintenance AD as recommended by national guidelines (2005) continuing AD at minimal

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with major depressive disorder (DSM-IV) with at least two previous depressive episodes in the past five years. Last episode was treated succesfully with an antidepressant and the patient is still using that antidepressant at an adequate dose (recommended minimum dose according to Farmacotherapeutisch Kompas. Currently in remission according to DSM-IV criteria, for at least 8 weeks and no longer than 2 years. A current score of

Exclusion criteria

Exclusion criteria: * Bipolar I of bipolar II disorder (indicated by previous or current manic or hypomanic episode (DSM-IV) * serious neurological or somatic disorder (including organic brain damage) as possible cause of depression * alcohol or drug abuse during the last six months; alcohol or drug dependence during two years * comorbid anxiety disorder, necessitating additional treatment * ongoing or recent (

Design outcomes

Primary

MeasureTime frame
Proportion of relapse/recurrence in a survival analysis over a follow up period of 2 years using DSM-IV criteria as assessed bij the Structural Interview for DSM-IV (SCID I) at 3, 12 and 24 months (current depressive symptomatology and previous 3 and 6 months). Assessment HDSR at screening, 3, 12 en 24 months.

Secondary

MeasureTime frame
Number of Episodes and severity of depression: SCID-I and Inventory of Depression Symptomatology (IDS-SR 18). Predictors and mediators: avoidance of emotions: AAQ II rumination: RRS-uitgebreide extended version Dysfunctional attitude scale (DAS-A) Attribution Style (DASQ and LEIDS) Every Day Problem Checklist (EPCL 20) Negative Life Events Questionnaire (NLEQ 21) Coping (UCL) Assess medication adherence: Medication Adherence Questionnaire (MAQ22) Economic evaluation: quality adjusted life years (EQ5D) Implicit attitudes en attentional bias Impliciete Associatie test (IAT24) Assess the difficulty to disengage from negative information: Rapid Serial Visual Presentation (RSVP) task New addition June 5 2013: Effect in daily life: PsyMate DNA-assessment: Saliva sample

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)