Antidepressants Clinical Trial
Official title:
Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.
To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.
Antidepressant use continues to rise, mainly explained by an increase in the proportion of
patients receiving long term treatment. Although treatment guidelines recommend
discontinuation after sustained remission, discontinuing antidepressants appears to be
challenging for both patients and general practitioners. Mindfulness-Based Cognitive Therapy
(MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression
and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms
and fear of relapse. The current study aims to investigate the effectiveness of the
combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD
alone in successful discontinuation of long-term use of antidepressants in primary care.
Methods/Design This study involves a cluster-randomized controlled trial conducted in primary
care patients with long-term use antidepressants with baseline and 6, 9 and 12 months
follow-up assessments. Patients choosing to discontinue their medication will be offered a
combination of supported protocolized discontinuation (SPD) and MBCT or SPD alone. Our
primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6
months after baseline assessment. Secondary outcome measures will be the severity of
withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of
life and medical and societal costs.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05051995 -
Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms
|
N/A | |
| Recruiting |
NCT05191277 -
Disentangling Pharmacological and Expectation Effects in Antidepressant Discontinuation
|
N/A | |
| Not yet recruiting |
NCT06337539 -
Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants
|