AnorexiaNCT06146075
Insights Into Participating in Clinical Studies for Anorexia
An observational study of Anorexia, run by Power Life Sciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Anorexia patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating women
- Any serious and/or unstable pre-existing medical disorders
- Patients receiving any other investigational agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Assessing Engagement Patterns and Participation Trends in Individuals Joining Anorexia Clinical Trials
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.
- Conditions
- Anorexia
- Keywords
- anorexia
- Medical subject headings
- Anorexia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in an anorexia clinical research
Measured: 3 months
Rate of patients who remain in an anorexia clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Michael, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146075
- Sponsor's protocol ID
- 65794646
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34543514Matsuo 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.
PubMed 27539132Tanahashi 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.
PubMed 28824707
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Engagement Patterns and Participation Trends in Individuals Joining Anorexia Clinical Trials
- ClinicalTrials.gov ID
- NCT06146075
- Acronym / sponsor ID
- 65794646
- Conditions
- Anorexia
- Keywords
- anorexia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anorexia patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Any serious and/or unstable pre-existing medical disorders
- Patients receiving any other investigational agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to enroll in an anorexia clinical research
Time frame: 3 months
Rate of patients who remain in an anorexia clinical trial to trial completion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 34543514Peters 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.
- Background: PubMed 27539132Matsuo 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.
- Background: PubMed 28824707Tanahashi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Michael study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to enroll in an anorexia clinical research (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146075, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.