Percent Change in Body Weight
| Group | Value (% change) | Spread |
|---|---|---|
| Active Drug | -3.3 | 5.2 |
| Placebo | 0.2 | 4.2 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)
NCT0315880526 Apr 2017 to 1 Jan 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will reduce body weight and improve metabolic variables in obese or overweight patients with BP without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc injection will display greater efficacy as compared to placebo in decreasing body weight in patients with BP who are obese or overweight. To prove this hypothesis, investigators will conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with stable BP. The investigators have chosen BP rather than another SMI because it is the most common SMI (more common than schizophrenia or schizoaffective disorder) and has a particularly strong association with obesity.
Active comparator
Active drug
LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
Placebo comparator
Placebo
Placebo (no active drug)
Outcomes the sponsor listed as primary.
Percent Change in Body Weight
Time frame · 40 week
Percent change in body weight over 40 weeks
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (% change) | Spread |
|---|---|---|
| Active Drug | -3.3 | 5.2 |
| Placebo | 0.2 | 4.2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Active DrugSignificantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued liraglutide stopped because of gastrointestinal issues (n=1), mood dysregulation (n=1), and suicidal ideation (n=1). No adverse event was judged to reflect an interaction between liraglutide and participants' BD medications. There were no changes in psychopathology safety scales or vital signs. No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study. | 0 / 29 | 0 / 29 | 29 / 29 |
| PlaceboSignificantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued placebo did so for mood dysregulation (n=5), gastrointestinal issues (n=4), and suicidal ideation (n=2). Two participants receiving placebo had a serious adverse event- one was medically hospitalized for a bowel obstruction presumed due to past bariatric surgery while the other was psychiatrically hospitalized for mood dysregulation-neither adverse event was attributed to study medication. There were no changes in psychopathology safety scales or vital signs . No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study. | 0 / 31 | 2 / 31 | 25 / 31 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2024
McElroy et al. 2024Journal of clinical psychopharmacologycited by 25
PMID 38227621DOI 10.1097/jcp.0000000000001803PUB-38227621
Who could join, as posted.
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