← Back to Search

Biguanide

Metformin for Bipolar Disorder (MOBILITY Trial)

Phase 4
Waitlist Available
Led By Melissa P DelBello, MD, MS
Research Sponsored by Melissa Delbello
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screen/baseline to visit 24
Awards & highlights

MOBILITY Trial Summary

This trial will study the impact of METFORMIN and a healthy lifestyle intervention (LIFE) on patient-centered outcomes including body weight, psychiatric symptom burden, and Quality of Life.

Eligible Conditions
  • Bipolar Disorder

MOBILITY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screen/baseline to visit 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and screen/baseline to visit 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI z-score
Secondary outcome measures
Composite Metabolic Health and Nutrition Measure

MOBILITY Trial Design

2Treatment groups
Experimental Treatment
Group I: MET and LIFEExperimental Treatment2 Interventions
Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile <5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age > 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation.
Group II: Healthy lifestyle intervention (LIFE)Experimental Treatment1 Intervention
Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
healthy lifestyle intervention (LIFE)
2015
Completed Phase 4
~1570

Find a Location

Who is running the clinical trial?

Melissa DelbelloLead Sponsor
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,995,211 Total Patients Enrolled
5 Trials studying Bipolar Disorder
1,041,609 Patients Enrolled for Bipolar Disorder
Melissa P DelBello, MD, MSPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Bipolar Disorder
214 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Child Center of New York,
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
Melissa Delbello 2015. "Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02515773.
~168 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top