Insights Into Participating in Clinical Studies for Anorexia
Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06146075
Collaborator
(none)
500
1
24
20.8
Study Details
Study Description
Brief Summary
Clinical trials centered on anorexia serve a pivotal function in assessing the safety and effectiveness of emerging treatments for this condition.
The primary aim revolves around meticulously scrutinizing both trial completion rates and instances of voluntary withdrawal within specific patient cohort.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Assessing Engagement Patterns and Participation Trends in Individuals Joining Anorexia Clinical Trials
Anticipated Study Start Date
:
Dec 1, 2024
Anticipated Primary Completion Date
:
Dec 1, 2025
Anticipated Study Completion Date
:
Dec 1, 2026
Outcome Measures
Primary Outcome Measures
- Number of patients who decide to enroll in an anorexia clinical research [3 months]
- Rate of patients who remain in an anorexia clinical trial to trial completion [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
-
Diagnosis of anorexia
-
No prior treatment for anorexia
Exclusion Criteria:
-
Pregnant or lactating women
-
Any serious and/or unstable pre-existing medical disorders
-
Patients receiving any other investigational agents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Power Life Sciences | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Michael, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- Matsuo N, Morita T, Matsuda Y, Okamoto K, Matsumoto Y, Kaneishi K, Odagiri T, Sakurai H, Katayama H, Mori I, Yamada H, Watanabe H, Yokoyama T, Yamaguchi T, Nishi T, Shirado A, Hiramoto S, Watanabe T, Kohara H, Shimoyama S, Aruga E, Baba M, Sumita K, Iwase S. Predictors of responses to corticosteroids for anorexia in advanced cancer patients: a multicenter prospective observational study. Support Care Cancer. 2017 Jan;25(1):41-50. doi: 10.1007/s00520-016-3383-z. Epub 2016 Aug 18.
- Peters K, Meule A, Voderholzer U, Rauh E. Effects of interval-based inpatient treatment for anorexia nervosa: An observational study. Brain Behav. 2021 Nov;11(11):e2362. doi: 10.1002/brb3.2362. Epub 2021 Sep 20.
- Tanahashi T, Kawai K, Tatsushima K, Saeki C, Wakabayashi K, Tamura N, Ando T, Ishikawa T. Purging behaviors relate to impaired subjective sleep quality in female patients with anorexia nervosa: a prospective observational study. Biopsychosoc Med. 2017 Aug 16;11:22. doi: 10.1186/s13030-017-0107-7. eCollection 2017. Erratum In: Biopsychosoc Med. 2018 Mar 15;12 :5.
Responsible Party:
Power Life Sciences Inc.
ClinicalTrials.gov Identifier:
NCT06146075
Other Study ID Numbers:
- 65794646
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023