Generalized Anxiety DisorderNCT06254157
Understanding of Participation Trends Within Generalized Anxiety Disorder Patients Involved in Clinical Trials
An observational study of Generalized Anxiety Disorder, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Typically, certain demographic groups tend to participate more in medical research. However, there is insufficient research explaining the trial characteristics that influence the involvement of these specific demographics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2025to Mar 2027
- 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: Individuals with generalized anxiety disorder who are actively contemplating involvement in a clinical trial but have not yet completed the enrollment and randomization process.
Who may be able to join
- Confirmed diagnosis of generalized anxiety disorder
- Participant must be 18 years of age or older
- Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
Who cannot join
- Pregnant or lactating woman
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
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: Generalized Anxiety Disorder Clinical Trials: An Analysis Regarding Engagement Trends and Participation of Generalized Anxiety Disorder Patients Involved in Clinical Trials
Typically, certain demographic groups tend to participate more in medical research. However, there is insufficient research explaining the trial characteristics that influence the involvement of these specific demographics.
This study aims to collect extensive data on the clinical trial experiences of individuals with generalized anxiety disorder. The goal is to identify the factors that hinder a patient's enrollment or completion of a trial.
Additionally, the research will examine the data from various demographic perspectives to identify recurring patterns that could offer valuable insights for future generalized anxiety disorder patients.
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety disorder
- Medical subject headings
- Generalized Anxiety Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a generalized anxiety disorder clinical research.
Measured: 3 months
Number of generalized anxiety disorder study participants who remain in clinical study until 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 posted12 Feb 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (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 Generalized Anxiety DisorderStudies 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
- NCT06254157
- Sponsor's protocol ID
- 57777066
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Slee A, Nazareth I, Bondaronek P, Liu Y, Cheng Z, Freemantle N. Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis. Lancet. 2019 Feb 23;393(10173):768-777. doi: 10.1016/S0140-6736(18)31793-8. Epub 2019 Jan 31.
PubMed 30712879Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.
PubMed 18363421Santiago J, Akeman E, Kirlic N, Clausen AN, Cosgrove KT, McDermott TJ, Mathis B, Paulus M, Craske MG, Abelson J, Martell C, Wolitzky-Taylor K, Bodurka J, Thompson WK, Aupperle RL. Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder. Trials. 2020 Jan 6;21(1):17. doi: 10.1186/s13063-019-3802-9.
PubMed 31907032
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Anxiety Disorder Clinical Trials: An Analysis Regarding Engagement Trends and Participation of Generalized Anxiety Disorder Patients Involved in Clinical Trials
- ClinicalTrials.gov ID
- NCT06254157
- Acronym / sponsor ID
- 57777066
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Feb 2024 (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.
Typically, certain demographic groups tend to participate more in medical research. However, there is insufficient research explaining the trial characteristics that influence the involvement of these specific demographics.
This study aims to collect extensive data on the clinical trial experiences of individuals with generalized anxiety disorder. The goal is to identify the factors that hinder a patient's enrollment or completion of a trial.
Additionally, the research will examine the data from various demographic perspectives to identify recurring patterns that could offer valuable insights for future generalized anxiety disorder patients.
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
- Individuals with generalized anxiety disorder who are actively contemplating involvement in a clinical trial but have not yet completed the enrollment and randomization process.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of generalized anxiety disorder
- Participant must be 18 years of age or older
- Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
Key exclusion criteria (3 listed)
- Pregnant or lactating woman
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
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
Rate of patients who decide to enroll in a generalized anxiety disorder clinical research.
Time frame: 3 months
Number of generalized anxiety disorder study participants who remain in clinical study until 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 12 Feb 2024.
- Background: PubMed 30712879Slee A, Nazareth I, Bondaronek P, Liu Y, Cheng Z, Freemantle N. Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis. Lancet. 2019 Feb 23;393(10173):768-777. doi: 10.1016/S0140-6736(18)31793-8. Epub 2019 Jan 31.
- Background: PubMed 18363421Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.
- Background: PubMed 31907032Santiago J, Akeman E, Kirlic N, Clausen AN, Cosgrove KT, McDermott TJ, Mathis B, Paulus M, Craske MG, Abelson J, Martell C, Wolitzky-Taylor K, Bodurka J, Thompson WK, Aupperle RL. Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder. Trials. 2020 Jan 6;21(1):17. doi: 10.1186/s13063-019-3802-9.
- 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 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 Generalized Anxiety Disorder, 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 12 Feb 2024. 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?
Rate of patients who decide to enroll in a generalized anxiety disorder 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 NCT06254157, 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 12 Feb 2024.