- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368855
GLP-1 Medicines and Mental Health Changes
Changes in Psychiatric Symptoms, Eating Disorder Behaviors, and Health Behaviors Following Six Months of GLP-1 Treatment for Obesity
Key question: Is the use of GLP-1 weight loss medicines - semaglutide and tirzepatide - associated with improvements in mental health and health-related quality of life?
Key finding: Across six- months of GLP-1 treatment, participants reported statistically significant improvements in mental health, eating disorder symptoms, and health-related quality of life domains such as pain interference and sleep quality.
Message for readers: Although GLP-1 medicines are prescribed primarily for weight loss and metabolic health benefits, growing evidence suggests that these medicines may also facilitate meaningful improvements in mental health and quality of life.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veterans receiving care at the VA San Diego Healthcare System
Exclusion Criteria:
- VASDHS Veterans not receiving GLP-1 medicines for obesity through the weight control clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: GLP-1 medicine
GLP-1 treatment
|
Wegovy or Zepbound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory-2
Time Frame: Six months
|
Changes in BDI-2 scores
|
Six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Behavioral Symptoms
- Overweight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Personal Satisfaction
- Obesity
- Depression
- Psychological Well-Being
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Gastrointestinal Hormones
- Glucagon-Like Peptides
- Proglucagon
- Glucagon-Like Peptide 1
Other Study ID Numbers
- E250185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on GLP-1
-
Wonkwang University HospitalCompletedDelayed Gastric Emptying | Residual Gastric ContentsSouth Korea
-
University of South CarolinaPrisma Health-UpstateRecruitingObesity (Disorder) | Obesity Type 2 Diabetes MellitusUnited States
-
Zealand PharmaProfil Institut für Stoffwechselforschung GmbHTerminatedSafety and TolerabilityGermany
-
Ludwig-Maximilians - University of MunichGerman Research Foundation; Merck Sharp & Dohme LLCCompletedHyperglycemiaGermany
-
Zealand PharmaCompleted
-
Emory UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruitingDiabetes Mellitus, Type 2United States
-
Shanghai Zhongshan HospitalRecruiting
-
University Hospital, Strasbourg, FranceCentre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118Not yet recruitingClaudication, Intermittent | Peripheral Arterial Disease (PAD) | Chronic Limb-Threatening IschemiaFrance
-
University Hospital TuebingenMerck Sharp & Dohme LLCWithdrawn
-
Indiana UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHealthy | Type 2 Diabetes MellitusUnited States