At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,565 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics
In Brief
A Phase 4 clinical trial evaluating Metformin and healthy lifestyle intervention (LIFE) for Bipolar Disorder. Completed, enrolled 1,565 participants across 29 sites.
Detailed Summary
A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartDec 2015
Primary CompletionDec 2022
Study CompletionJun 2023
TodayJul 2026
First PostedAug 5, 2015
Enrollment StartDec 1, 2015
Primary CompletionDec 1, 2022
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 10.9 years ago
Interventions
Metformindrug
Metformin - to achieves maximum insulin-sensitizing effects
healthy lifestyle intervention (LIFE)behavioral
Healthy Life style intervention