Pioglitazone in Patients With Mood Disorders

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT01559857

Run by

Stanford University

People needed

37

Starts

2011-11-01

Expected to finish

2014-06-01

Last updated by the study team

2017-05-10

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 12 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months
• Willingness to sign human subjects consent form

You may not qualify if…

• Diagnosis of possible or probable cognitive impairment
• For women only: pregnancy, breastfeeding
• Personal history of Type I or Type II diabetes
• Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year
• Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 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

Where it is running

• Stanford University Department of Psychiatry & Behavioral Sciences — Palo Alto, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.