A Phase 4 interventional study of Metformin and healthy lifestyle intervention (LIFE) in Bipolar Disorder, sponsored by Melissa Delbello. Completed at 29 sites in United States. Open to participants aged 8 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Melissa Delbello · Phase 4, Interventional, and Treatment
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.
The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24 public and private mental health practices in the Greater Cincinnati and New York City regions, (approximately 900 each from \~12 Cincinnati region and \~12 Long Island/New York mental health treatment sites) to participate in the proposed patient-centered large pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI > 85%), continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia, or bipolar or mood disorder not otherwise specified [or by Diagnostic and Statistical Manual of Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment rate will be 2-3 patients/month/site for a recruitment time of 30 months.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 1,565 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →This is the only study on the registry with Melissa Delbello as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Metformin · Behavioral: healthy lifestyle intervention (LIFE)
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).
Behavioral: healthy lifestyle intervention (LIFE)
Metformin - to achieves maximum insulin-sensitizing effects
Also known as: GLUCOPHAGE
Healthy Life style intervention
Also known as: LIFE
Change in BMI Z-score From Baseline to Month 6 in ITT Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Time frame: Baseline to Month 6
Change in BMI Z-score From Baseline to Month 24 in ITT Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Time frame: Baseline to Month 24
Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Time frame: Baseline to Month 6
Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Time frame: Baseline to Month 24
| Milestone | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| Started | 579 | 720 |
| Followed randomized treatment (per-protocol sample) | 558 | 686 |
| Completed | 360 | 454 |
| Not completed | 219 | 266 |
| Withdrew: Withdrawal by subject | 12 | 2 |
| Withdrew: Lost to follow-up | 119 | 126 |
| Withdrew: Discharged from clinic services | 53 | 84 |
| Withdrew: Censored (study ended before participant could complete) | 18 | 24 |
| Withdrew: Follow-up at non-study site | 8 | 16 |
| Withdrew: Moved from area | 9 | 14 |
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
| Z-score | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| Change in BMI Z-score From Baseline to Month 6 in ITT Sample | -0.08 ± 0.29 | 0.00 ± 0.29 |
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
| Z-score | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| Change in BMI Z-score From Baseline to Month 24 in ITT Sample | -0.19 ± 1.00 | -0.11 ± 0.87 |
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
| Z-score | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample | -0.09 ± 0.46 | 0.00 ± 0.42 |
Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
| Z-score | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample | -0.21 ± 1.11 | -0.12 ± 1.01 |
Collected over 30 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MET and LIFE | 0/579 (0%) | 12/579 (2.1%) | 352/558 (63.1%) |
| Healthy Lifestyle Intervention (LIFE) | 0/720 (0%) | 25/720 (3.5%) | 339/686 (49.4%) |
| Event | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| abdominal painGeneral disorders | 5/579 | 1/720 |
| pneumoniaGeneral disorders | 0/579 | 3/720 |
| pyelonephritisGeneral disorders | 0/579 | 3/720 |
| urethral/kidney stoneGeneral disorders | 0/579 | 3/720 |
| infectionGeneral disorders | 0/579 | 3/720 |
| refractory headachesGeneral disorders | 2/579 | 0/720 |
| complications of tonsillectomyGeneral disorders | 2/579 | 2/720 |
| seizuresGeneral disorders | 1/579 | 2/720 |
| allergic reactionGeneral disorders | 0/579 | 2/720 |
| neck dystoniaGeneral disorders | 1/579 | 0/720 |
| Event | MET and LIFE | Healthy Lifestyle Intervention (LIFE) |
|---|---|---|
| NauseaGastrointestinal disorders | 117/558 | 69/686 |
| Stomach CrampsGastrointestinal disorders | 110/558 | 57/686 |
| DiarrheaGastrointestinal disorders | 105/558 | 40/686 |
| FlatulenceGastrointestinal disorders | 83/558 | 53/686 |
| Increased AppetiteGeneral disorders | 56/558 | 91/686 |
| VomitingGastrointestinal disorders | 70/558 | 32/686 |
| SedationGeneral disorders | 20/558 | 41/686 |
| HeadacheGeneral disorders | 24/558 | 31/686 |
| FatigueGeneral disorders | 11/558 | 21/686 |
| SomnolenceGeneral disorders | 14/558 | 20/686 |
Modified intent-to-treat sample, which includes all randomized patients who had a post-randomization visit and started their randomized intervention.
| Age, Continuous(Years) | MET and LIFE | Healthy Lifestyle Intervention (LIFE) | Total |
|---|---|---|---|
| Mean | 14.0 ± 2.8 | 13.8 ± 2.9 | 13.9 ± 2.9 |
| Sex: Female, Male(Participants) | MET and LIFE | Healthy Lifestyle Intervention (LIFE) | Total |
|---|---|---|---|
| Female | 273 | 341 | 614 |
| Male | 306 | 379 | 685 |
| Ethnicity (NIH/OMB)(Participants) | MET and LIFE | Healthy Lifestyle Intervention (LIFE) | Total |
|---|---|---|---|
| Hispanic or Latino | 60 | 96 | 156 |
| Not Hispanic or Latino | 517 | 624 | 1141 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | MET and LIFE | Healthy Lifestyle Intervention (LIFE) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 3 | 6 |
| Asian | 11 | 13 | 24 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 98 | 124 | 222 |
| White | 399 | 472 | 871 |
| More than one race | 50 | 78 | 128 |
| Unknown or Not Reported | 17 | 29 | 46 |
| BMI Z-Score(Z-score) | MET and LIFE | Healthy Lifestyle Intervention (LIFE) | Total |
|---|---|---|---|
| Mean | 1.90 ± 0.48 | 1.85 ± 0.46 | 1.87 ± 0.47 |
| Obesity(Participants) | MET and LIFE | Healthy Lifestyle Intervention (LIFE) | Total |
|---|---|---|---|
| Count of participants | 385 | 474 | 859 |
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