Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
It has been widely recognized that the placebo effect has a profound impact on treatment
outcome in many different conditions. Recent studies imply that this effect appears even if
placebos are openly administered; so called "open-label placebos" (OLP). Compelling evidence
suggests the efficacy of OLP in the treatment of pain disorders, neuropsychological
syndromes, menopausal hot flushes, depression and allergic rhinitis. Research on the
underlying mechanisms of OLP is scarce, yet studies indicate that psychological mechanisms as
well as neurobiological processes related to expectation- and prediction mechanisms may play
a role. While these effects have been linked to OLP as additional treatment, to date, it has
not been examined whether OLP could support discontinuation of drug treatments.
Antidepressant discontinuation has been frequently associated with negative side effects,
interfering with the discontinuation process and generally discouraging discontinuation.
Patients frequently report negative expectations towards the discontinuation process, such as
fear of experiencing a relapse and negative side effects. Interestingly, OLP may support
antidepressant discontinuation, not only through the generation of (positive) expectations,
but also mechanisms related to habituation (i.e. taking pills). The objective of this study
is to investigate whether OLP is efficacious in reducing negative side effects caused by
discontinuation of antidepressant medication.
Phase:
N/A
Details
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborators:
Helmut Schmidt University Universitätsklinikum Marburg University Hospital, Essen