Evidence map›Paper›PMID 37833651›Full record

ArticleBMC psychiatry2023

Study protocol: combined N-of-1 trials to assess open-label placebo treatment for antidepressant discontinuation symptoms [FAB-study].

Amke Müller, Stefan Konigorski, Carina Meißner, Tahmine Fadai, Claire V Warren, Irina Falkenberg, Tilo Kircher, Yvonne Nestoriuc

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05051995 (Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05051995 nacompletednot on this map

Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2022 to 2024Enrolled25ConditionsDepressive Symptoms, Expectations, AntidepressantsArmsOpen-label placebo, No-treatment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Amke MüllerClinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Holstenhofweg 85, 22043, Hamburg, Germany. muellera@hsu-hh.de.ORCID http://orcid.org/0000-0003-4136-2326
Stefan KonigorskiDigital Health - Machine Learning Group, Hasso-Plattner-Institute for Digital Engineering, Potsdam, Germany.
Carina MeißnerClinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Holstenhofweg 85, 22043, Hamburg, Germany.
Tahmine FadaiInstitute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Claire V WarrenClinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Holstenhofweg 85, 22043, Hamburg, Germany.
Irina FalkenbergDepartment of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany.
Tilo KircherDepartment of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany.
Yvonne NestoriucClinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Holstenhofweg 85, 22043, Hamburg, Germany.
Universität Hamburg · DEPhilipps University of Marburg · DEHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntidepressant discontinuation is associated with a broad range of adverse effects. Debilitating discontinuation symptoms can impede the discontinuation process and contribute to unnecessary long-term use of antidepressants. Antidepressant trials reveal large placebo effects, indicating a potential use of open-label placebo (OLP) treatment to facilitate the discontinuation process. We aim to determine the effect of OLP treatment in reducing antidepressant discontinuation symptoms using a series of N-of-1 trials.

methodsA series of randomized, single-blinded N-of-1 trials will be conducted in 20 patients with fully remitted DSM-V major depressive disorder, experiencing moderate to severe discontinuation symptoms following antidepressant discontinuation. Each N-of-1 trial consists of two cycles, each comprising two-week alternating periods of OLP treatment and of no treatment in a random order, for a total of eight weeks. Our primary outcome will be self-reported discontinuation symptoms rated twice daily via the smartphone application 'StudyU'. Secondary outcomes include expectations about discontinuation symptoms and (depressed) mood. Statistical analyses will be based on a Bayesian multi-level random effects model, reporting posterior estimates of the overall and individual treatment effects. DISCUSSION: Results of this trial will provide insight into the clinical application of OLP in treating antidepressant discontinuation symptoms, potentially offering a new cost-effective therapeutic tool. This trial will also determine the feasibility and applicability of a series of N-of-1 trials in a clinical discontinuation trial.

trial registrationClinicalTrials.gov: NCT05051995, first registered September 20, 2021.

Indexed as

Major Depressive DisorderAntidepressive AgentsBayes TheoremHumansRandomized Controlled Trials as TopicResearch DesignAntidepressive AgentsAntidepressant withdrawalDepressive disorderNoceboN-of-1PlaceboSide-effectsSNRISSRITreatment expectation

Identifiers

PMID37833651
PMCPMC10576328
OpenAlexW4387615048

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.