Depressive Disorder, Major, Metabolic Syndrome X
Conditions
Keywords
Depressive Disorder, Major, Metabolic Syndrome X, pioglitazone
Brief 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).
Interventions
DRUGPioglitazone
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Sponsors
Takeda Pharmaceuticals North America, Inc.
Joseph Calabrese, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Symptom Severity From Baseline to Study Endpoint | Week 0 - Week 12 | Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint | Week 0-Week 12 | The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pioglitazone An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Pioglitazone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 44.6 years STANDARD_DEVIATION 10.2 |
| Gender Female | 20 Participants |
| Gender Male | 3 Participants |
| Region of Enrollment United States | 23 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Change in Depression Symptom Severity From Baseline to Study Endpoint
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
Time frame: Week 0 - Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone | Change in Depression Symptom Severity From Baseline to Study Endpoint | -20.9 Units on a scale | Standard Deviation 12.1 |
Secondary
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.
Time frame: Week 0-Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pioglitazone | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint | -0.810 units on a scale | Standard Deviation 0.748 |