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NCT06101914 Clinical Trial

Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients

Treatment Resistant Depression Clinical Trial

Official title:
Evaluating the Occurrence of Engagement Patterns and Participation Trends Among Patients in Treatment Resistant Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06101914
Other study ID # 64175778
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2024
Est. completion date November 2026

Study information
Verified date October 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date November 2026
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of patients who decide to enroll in a treatment resistant depression clinical research. 3 months
Primary Number of treatment resistant depression study participants who remain in clinical study until completion. 12 months
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