Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Treatment Resistant Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Occurrence of Engagement Patterns and Participation Trends Among Patients in Treatment Resistant Depression
Overview
Clinical studies, with a distinct focus on treatment resistant depression, play a crucial role in evaluating the safety and effectiveness of novel treatments. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.
Primary outcome measures
- Rate of patients who decide to enroll in a treatment resistant depression clinical research. [Time frame: 3 months]
- Number of treatment resistant depression study participants who remain in clinical study until completion. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of treatment resistant depression
- Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- No prior treatment for treatment resistant depression
Exclusion criteria
- Enrolled in another research study
- Inability to provide written informed consent
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Power Life Sciences — San Francisco
Publications
- Lundberg J, Cars T, Loov SA, Soderling J, Sundstrom J, Tiihonen J, Leval A, Gannedahl A, Bjorkholm C, Sjalin M, Hellner C. Association of Treatment-Resistant Depression With Patient Outcomes and Health Care Resource Utilization in a Population-Wide Study. JAMA Psychiatry. 2023 Feb 1;80(2):167-175. doi: 10.1001/jamapsychiatry.2022.3860. PMID 36515938
- Perez-Sola V, Roca M, Alonso J, Gabilondo A, Hernando T, Sicras-Mainar A, Sicras-Navarro A, Herrera B, Vieta E. Economic impact of treatment-resistant depression: A retrospective observational study. J Affect Disord. 2021 Dec 1;295:578-586. doi: 10.1016/j.jad.2021.08.036. Epub 2021 Aug 27. PMID 34509073
- Wilkowska A, Wlodarczyk A, Galuszko-Wegielnik M, Wiglusz MS, Cubala WJ. Intravenous Ketamine Infusions in Treatment-Resistant Bipolar Depression: An Open-Label Naturalistic Observational Study. Neuropsychiatr Dis Treat. 2021 Aug 14;17:2637-2646. doi: 10.2147/NDT.S325000. eCollection 2021. PMID 34421299
Identifiers
NCT: NCT06101914 · 64175778