Trial Outcomes & Findings for Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome (NCT NCT00671515)

Last Updated: 2017-01-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Week 0 - Week 12

Results posted on

2017-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Phase 1 STARTED	23
Phase 1 COMPLETED	20
Phase 1 NOT COMPLETED	3
Phase 2 STARTED	13
Phase 2 COMPLETED	9
Phase 2 NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone n=23 Participants An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.6 years STANDARD_DEVIATION 10.2 • n=5 Participants
Gender Female	20 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 - Week 12

Outcome measures

Outcome measures
Measure	Pioglitazone n=23 Participants An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Change in Depression Symptom Severity From Baseline to Study Endpoint	-20.9 Units on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pioglitazone n=23 Participants An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
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

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pioglitazone n=23 participants at risk An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
General disorders Headache	26.1% 6/23 • Number of events 6
General disorders Dizziness/Lightheadedness	21.7% 5/23 • Number of events 5
General disorders Increased Appetite	17.4% 4/23 • Number of events 4
General disorders Weight Gain	17.4% 4/23 • Number of events 4
Musculoskeletal and connective tissue disorders Ankle/Leg Pain	17.4% 4/23 • Number of events 4
Eye disorders Blurred Vision	13.0% 3/23 • Number of events 3
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2
General disorders Sedation	8.7% 2/23 • Number of events 2
General disorders Hot Flashes	8.7% 2/23 • Number of events 2
General disorders Insomnia	8.7% 2/23 • Number of events 2
Skin and subcutaneous tissue disorders Itching	8.7% 2/23 • Number of events 2

Additional Information

Dr. Joseph Calabrese

University Hospitals Cleveland Medical Center

Phone: 216-844-2865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place