Phase 4 N=37 Randomized Quadruple-blind Treatment

Pioglitazone in Patients With Mood Disorders

Major Depressive Disorder · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT01559857 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Hamilton Depression Rating Scale at Baseline — 15.22; 13.67; 19.22; 13.25 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pioglitazone (Drug); Sugar Pill (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Depression Rating Scale at Baseline	15.22; 13.67; 19.22; 13.25	—
SECONDARY Fasting Insulin Measurements at Baseline	10.61; 9.18; 13.98; 14.12	—
SECONDARY Change in HDRS-21: From Baseline to 12 Weeks	-4.45; -3.57; -1.71; -3.57	—

Summary

The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can cause changes in mood in some depressed patients. Study participants receive assessment of their cognitive and metabolic functioning. If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a 90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting insulin and glucose levels, as well as routine blood testing. The investigators hope to quantify the role of Pioglitazone in patients with mood disorders and compare the values to those previously obtained in a healthy age-matched control population. The investigators also hope to examine the association between IR and cognitive performance and clinical course of depression in patients with mood disorders.

Eligibility Criteria

Inclusion Criteria

Age between 20 and 65 years
BMI between 25 and 35
Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS)
Depression severity as defined by score of 170 or diastolic blood pressures > 100)
Current drug or alcohol abuse
History of neurological disorder, e.g. multiple sclerosis, stroke etc
Use of any drug that may significantly affect psychometric testing or the insulin testing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01559857). 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.