Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Cleveland Medical Center - Mood Disorders Program | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Joseph Calabrese, MD
- Takeda Pharmaceuticals North America, Inc.
Investigators
- Principal Investigator: Joseph E Calabrese, MD, University Hospitals Cleveland Medical Center - Mood Disorders Program
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07-07-20
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pioglitazone |
|---|---|
| Arm/Group Description | An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
| Period Title: Phase 1 | |
| STARTED | 23 |
| COMPLETED | 20 |
| NOT COMPLETED | 3 |
| Period Title: Phase 1 | |
| STARTED | 13 |
| COMPLETED | 9 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Pioglitazone |
|---|---|
| Arm/Group Description | An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
| Overall Participants | 23 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
23
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
44.6
(10.2)
|
| Gender (Count of Participants) | |
| Female |
20
87%
|
| Male |
3
13%
|
| Region of Enrollment (participants) [Number] | |
| United States |
23
100%
|
Outcome Measures
| Title | Change in Depression Symptom Severity From Baseline to Study Endpoint |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pioglitazone |
|---|---|
| Arm/Group Description | An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
| Measure Participants | 23 |
| Mean (Standard Deviation) [Units on a scale] |
-20.9
(12.1)
|
| Title | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pioglitazone |
|---|---|
| Arm/Group Description | An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
| Measure Participants | 23 |
| Mean (Standard Deviation) [units on a scale] |
-0.810
(0.748)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Pioglitazone | |
| Arm/Group Description | An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. | |
All Cause Mortality |
||
| Pioglitazone | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Pioglitazone | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Pioglitazone | ||
| Affected / at Risk (%) | # Events | |
| Total | 20/23 (87%) | |
| Eye disorders | ||
| Blurred Vision | 3/23 (13%) | 3 |
| Gastrointestinal disorders | ||
| Nausea | 2/23 (8.7%) | 2 |
| General disorders | ||
| Headache | 6/23 (26.1%) | 6 |
| Dizziness/Lightheadedness | 5/23 (21.7%) | 5 |
| Increased Appetite | 4/23 (17.4%) | 4 |
| Weight Gain | 4/23 (17.4%) | 4 |
| Sedation | 2/23 (8.7%) | 2 |
| Hot Flashes | 2/23 (8.7%) | 2 |
| Insomnia | 2/23 (8.7%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Ankle/Leg Pain | 4/23 (17.4%) | 4 |
| Skin and subcutaneous tissue disorders | ||
| Itching | 2/23 (8.7%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Joseph Calabrese |
|---|---|
| Organization | University Hospitals Cleveland Medical Center |
| Phone | 216-844-2865 |
| Joseph.Calabrese@UHhospitals.org |
- 07-07-20