Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT
Primary result · PHQ-9 scoreResult — go to the resultEstimated treatment difference −0.6Authors' conclusion
In this post hoc analysis, tirzepatide versus placebo did not appear to be associated with an increased risk of depression in participants with overweight/obesity and without known major psychopathology. Rates of SI/SB observed with tirzepatide were similar to those of other incretin-based therapies. Further study of tirzepatide's safety in persons with significant psychiatric illness may be warranted.
Study context
- Population
- Adults with obesity without known major psychopathology
- Participants
- 4,056 adults
- Comparison
- Tirzepatide vs placebo
- Primary endpoint
- Depressive symptoms (PHQ-9) and SI/SB (Columbia-Suicide Severity Rating Scale (C-SSRS))
- Follow-up
- Week 72
Methodological detailsplacebo-controlled
- Placebo-controlled
Primary result
PHQ-9 score
Estimated treatment difference
−0.6
P < 0.001
By group
Tirzepatide
1.9
mean · SD 2.7
Placebo
2.4
mean · SD 3.3
As reported in the abstract
Further findings
Shift to a more severe PHQ-9 category
P < 0.001
Mean
| Outcome | Tirzepatide | Placebo |
|---|---|---|
| PHQ-9 at baselineNo/minimal symptoms of depression | 2.7 (SD 3.0) | 2.6 (SD 3.1) |
Safety
Suicidal ideation (C-SSRS) · most considered low risk
| Outcome | Tirzepatide | Placebo |
|---|---|---|
| Suicidal behaviour (nonfatal) | 0.1% | 0 events |
Nervous system and psychiatric adverse events (AEs)
- AEs were generally similar across groups
Original publication
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