Phase 4
Completed N=206
Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight
Source: ClinicalTrials.gov NCT00834652 ↗Enrolled (actual)
206
Serious AEs
0.5%
Results posted
Feb 2018
Primary outcomePrimary: Change of Beck Depression Inventory-II Scores Over 16 Weeks — 18.82; 17.50; 22.68; 22.03 units on a scale — p=<0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Beck Depression Inventory-II Scores Over 16 Weeks |
18.82; 17.50; 22.68; 22.03; 3.86; 4.53 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) greater than 28.7
- Positive screening for depression
- Must live within 100 miles of the St. Louis metropolitan area
Exclusion Criteria
- Pregnant or breastfeeding
- Known hypersensitivity to sertraline or metformin
- Recent history of heart attack or unstable heart disease
- Severe liver disease or kidney impairment, defined by a serum creatine level above 3 mg/dL
- Psychiatric disorder thought to affect management, such as schizophrenia, or alcohol or drug dependence
Data sourced from ClinicalTrials.gov (NCT00834652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.