Phase 2 N=23 Treatment

Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

Depressive Disorder, Major · Metabolic Syndrome X

Bottom Line

View on ClinicalTrials.gov: NCT00671515 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Change in Depression Symptom Severity From Baseline to Study Endpoint — -20.9 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pioglitazone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Joseph Calabrese, MD
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Depression Symptom Severity From Baseline to Study Endpoint	-20.9	—
SECONDARY Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint	-0.810	—

Summary

The goal of this study is to begin to test whether or not pioglitazone, an FDA approved medication used to treat high blood sugar, may be safe and effective in treating Major Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).

Eligibility Criteria

Inclusion Criteria

Be male or female between the ages of 18 and 70
DSM-IV diagnosis of major depressive disorder
Currently depressed as confirmed by the MINI-Plus at the screening visit
Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR) score > 11 at study baseline
Meets criteria for the metabolic syndrome as defined by the NCEP ATP III criteria

Exclusion Criteria

Pregnancy or breast feeding
Unstable or inadequately treated medical illness as judged by the investigator
Severe personality disorder
Serious suicidal risk as judged by the investigator or having a score > 2 on item 18 of the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) scale
Known history of intolerance or hypersensitivity to pioglitazone
Treatment with pioglitazone in the 3 months prior to randomization
Currently taking an antidiabetic/glucose-lowering agent. Antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
Diagnosed with dementia
Diagnosed with heart failure
Transaminase elevation >2.5 times the upper limit of normal
Presence of renal impairment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00671515). 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.