Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Joseph Calabrese, MD
With
Takeda Pharmaceuticals North America, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
