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Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06101914
Recruitment Status : Not yet recruiting
First Posted : October 26, 2023
Last Update Posted : October 26, 2023
Sponsor:
Information provided by (Responsible Party):
Power Life Sciences Inc.

Study Description
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Brief Summary:

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.


Condition or disease
Treatment Resistant Depression

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluating the Occurrence of Engagement Patterns and Participation Trends Among Patients in Treatment Resistant Depression
Estimated Study Start Date : November 2024
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of patients who decide to enroll in a treatment resistant depression clinical research. [ Time Frame: 3 months ]
  2. Number of treatment resistant depression study participants who remain in clinical study until completion. [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Treatment resistant depression patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06101914


Contacts
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Contact: Michael B Gill 4159004227 bask@withpower.com

Locations
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United States, California
Power Life Sciences
San Francisco, California, United States, 94107
Contact: Michael B Gill    415-900-4227    https://www.withpower.com/contact-us@withpower.com   
Sponsors and Collaborators
Power Life Sciences Inc.
Investigators
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Study Director: Michael B Gill Power Life Sciences Inc.
  Study Documents (Full-Text)

Documents provided by Power Life Sciences Inc.:
Informed Consent Form  [PDF] October 20, 2023

More Information
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Publications:

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Responsible Party: Power Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT06101914    
Other Study ID Numbers: 64175778
First Posted: October 26, 2023    Key Record Dates
Last Update Posted: October 26, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Power Life Sciences Inc.:
treatment resistant depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders