ArticleThe patient2019
Analysis of Clinical Trial Exit Interview Data in Patients with Treatment-Resistant Depression.
Article in The patient, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled 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.
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.
A Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose Frequency Study of Ketamine in Subjects With Treatment-resistant Depression
A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects With Treatment-Resistant Depression
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- The antidepressant effect and safety of non-intranasal esketamine: A systematic review.Journal of psychopharmacology (Oxford, England) · 2022Pooled it
- Beyond Numbers: Uses and Value of In-Trial Interview Data for Regulatory and Health Technology Assessment (HTA) Decision Making.The patient · 2026Review
- Article
- Exit Interviews Exploring Patients' Experience of Change in Crohn's Disease Symptoms During the Mirikizumab Phase 3 Clinical Trial In Adult Patients With Moderately-to-Severely Crohn's Disease.Crohn's & colitis 360 · 2025Article
- Exit Interviews Examining the Patient Experience in Clinical Trials of Tirzepatide for Treatment of Type 2 Diabetes.The patient · 2022Article
- Novel drug developmental strategies for treatment-resistant depression.British journal of pharmacology · 2022Review
- U.S. Food and Drug Administration's Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression.Therapeutic innovation & regulatory science · 2022Article
- Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews.Journal of patient-reported outcomes · 2021Article
- Satisfaction with mental health and psycho-social support services provided to Syrians under temporary protection in Turkey, evidence from refugee health training centers.Journal of migration and health · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical outcome assessments may not fully capture patients' perspectives of treatment benefit or tolerability. Incorporating individual exit interviews might enhance the description of the patient experience of drug effects.
objectiveThe objective of this study was to evaluate the patient treatment experience in a clinical trial of treatment-resistant depression utilizing exit interview methodology.
methodsIndividual patient interviews were conducted with subjects exiting two phase II clinical trials involving investigational agents for treatment-resistant depression. Interviews included standardized questions about patients' perceptions of health changes and interest in continued use of the investigational agent. Constant comparative analysis of blinded data was used to identify, code, and categorize the data followed by a subsequent analysis of unblinded data to evaluate any potential treatment differences.
resultsNinety subjects completed exit interviews across the two trials. Most subjects (90%, Trial 2001; 74%, Trial 2002) reported at least one health change. Most subjects rated these changes to be at least moderately important, with most being rated "very important" to "extremely important." After unblinding, participants receiving active therapy alone reported most of the positive health changes (80% of overall positive changes in Trial 2001, 89% in Trial 2002), whereas patients taking placebo alone reported the majority of negative health changes (57% in Trial 2002). Positive changes included not only anticipated changes in mood but also potential cognitive benefits such as mental alertness, improved sleep, and better concentration.
conclusionsStandardized interview data provided direct patient insight into the treatment experience from the patient perspective. Data from these interviews assisted in phase III endpoint selection by providing data on relevant concepts in the target treatment-resistant depression population receiving a new treatment, thus enabling the selection of tools to capture noted treatment effects and, by eliminating irrelevant constructs or measures, thereby reducing data "noise."
trial registrationClinicalTrials.gov NCT01640080; NCT01627782.
Indexed as
Identifiers
What OpenQuestion holds
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 OpenQuestion graph.