- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101914
Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients
Evaluating the Occurrence of Engagement Patterns and Participation Trends Among Patients in Treatment Resistant Depression
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michael B Gill
- Phone Number: 4159004227
- Email: bask@withpower.com
Study Locations
-
-
California
-
San Francisco, California, United States, 94107
- Power Life Sciences
-
Contact:
- Michael B Gill
- Phone Number: 415-900-4227
- Email: https://www.withpower.com/contact-us@withpower.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients who decide to enroll in a treatment resistant depression clinical research.
Time Frame: 3 months
|
3 months
|
Number of treatment resistant depression study participants who remain in clinical study until completion.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64175778
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Treatment Resistant Depression
-
Changping LaboratoryBeijing HuiLongGuan HospitalRecruitingTreatment-Resistant DepressionChina
-
Central Institute of Mental Health, MannheimCharite University, Berlin, Germany; German Federal Ministry of Education and... and other collaboratorsActive, not recruitingTreatment-resistant DepressionGermany
-
Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, Australia, France, United Kingdom, Belgium, Germany, Taiwan, Spain, Argentina, Mexico, Poland, Bulgaria, Malaysia, South Africa, Turkey, Finland, Korea, Republic of, Brazil, Austria, Sweden, Lithuania
-
Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, France, Belgium, Mexico, Canada, Brazil, Estonia, Hungary, Slovakia
-
University of OttawaCanadian Institutes of Health Research (CIHR)Completed
-
GH Research Ireland LimitedRecruitingTreatment-resistant DepressionIreland, Czechia
-
First Affiliated Hospital of Zhejiang UniversityRecruitingTreatment-resistant DepressionChina
-
University Hospital FreiburgBoston Scientific CorporationRecruitingTreatment-resistant DepressionGermany, France
-
Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, Poland, Germany, Spain, Czechia
-
Millennium Pharmaceuticals, Inc.WithdrawnTreatment-Resistant Depression