Clinical trial NCT06101914: Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients
Official title: Evaluating the Occurrence of Engagement Patterns and Participation Trends Among Patients in Treatment Resistant Depression
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Treatment Resistant Depression
Keywords: treatment resistant depression
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment resistant depression patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: 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.


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

Primary outcomes:
measure: Rate of patients who decide to enroll in a treatment resistant depression clinical research.
timeFrame: 3 months
measure: Number of treatment resistant depression study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.