DepressionNCT05937932
Exploring Clinical Study Experiences of People With Depression
An observational study of Depression, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
The study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: People with depression who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient has self-identified as planning to enroll in a clinical trial
- Patient has been diagnosed with depression
- Patient is a minimum of 18 years or older
Who cannot join
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient is pregnant
Trial locations and contacts
1 site in 1 country.
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: Inside Depression Clinical Trials: Patient Experiences Shared While Undergoing Clinical Trials
The study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.
By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future depression patients and play an active role in advancing medical research.
- Conditions
- Depression
- Keywords
- depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to participate in a depression clinical trial
Measured: 3 months
Rate of patients who remain in depression 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 posted10 Jul 2023
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 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 DepressionStudies 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 Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937932
- Sponsor's protocol ID
- 82303651
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fancourt D, Steptoe A, Bu F. Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study. Lancet Psychiatry. 2021 Feb;8(2):141-149. doi: 10.1016/S2215-0366(20)30482-X. Epub 2020 Dec 9.
PubMed 33308420Dawson SR, Mallen CD, Gouldstone MB, Yarham R, Mansell G. The prevalence of anxiety and depression in people with age-related macular degeneration: a systematic review of observational study data. BMC Ophthalmol. 2014 Jun 12;14:78. doi: 10.1186/1471-2415-14-78.
PubMed 24923726Matison AP, Mather KA, Flood VM, Reppermund S. Associations between nutrition and the incidence of depression in middle-aged and older adults: A systematic review and meta-analysis of prospective observational population-based studies. Ageing Res Rev. 2021 Sep;70:101403. doi: 10.1016/j.arr.2021.101403. Epub 2021 Jul 8.
PubMed 34246793
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inside Depression Clinical Trials: Patient Experiences Shared While Undergoing Clinical Trials
- ClinicalTrials.gov ID
- NCT05937932
- Acronym / sponsor ID
- 82303651
- Conditions
- Depression
- Keywords
- depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Jul 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.
The study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.
By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future depression patients and play an active role in advancing medical research.
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
- People with depression who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient has self-identified as planning to enroll in a clinical trial
- Patient has been diagnosed with depression
- Patient is a minimum of 18 years or older
Key exclusion criteria (3 listed)
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient is pregnant
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 participate in a depression clinical trial
Time frame: 3 months
Rate of patients who remain in depression clinical trial to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Background: PubMed 33308420Fancourt D, Steptoe A, Bu F. Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study. Lancet Psychiatry. 2021 Feb;8(2):141-149. doi: 10.1016/S2215-0366(20)30482-X. Epub 2020 Dec 9.
- Background: PubMed 24923726Dawson SR, Mallen CD, Gouldstone MB, Yarham R, Mansell G. The prevalence of anxiety and depression in people with age-related macular degeneration: a systematic review of observational study data. BMC Ophthalmol. 2014 Jun 12;14:78. doi: 10.1186/1471-2415-14-78.
- Background: PubMed 34246793Matison AP, Mather KA, Flood VM, Reppermund S. Associations between nutrition and the incidence of depression in middle-aged and older adults: A systematic review and meta-analysis of prospective observational population-based studies. Ageing Res Rev. 2021 Sep;70:101403. doi: 10.1016/j.arr.2021.101403. Epub 2021 Jul 8.
- 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. This study is not recruiting at the moment.
Michael B Gill 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 Depression, 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: status not confirmed, as of the sponsor's last update on 10 Jul 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?
Results are not available in the source record.
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 participate in a depression clinical trial (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 NCT05937932, 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 10 Jul 2023.