Trial Outcomes & Findings for Pioglitazone for the Treatment of Bipolar Depression (NCT NCT01717040)
NCT ID: NCT01717040
Last Updated: 2017-01-27
Results Overview
Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2017-01-27
Participant Flow
Participant milestones
| Measure |
Pioglitazone
Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
Placebo
Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Pioglitazone
Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
Placebo
Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Required Medication Change
|
0
|
1
|
|
Overall Study
New Substance Use Disorder
|
1
|
0
|
Baseline Characteristics
Pioglitazone for the Treatment of Bipolar Depression
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=17 Participants
Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
Placebo
n=20 Participants
Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.71 years
STANDARD_DEVIATION 12.071 • n=5 Participants
|
43.65 years
STANDARD_DEVIATION 12.979 • n=7 Participants
|
45.05 years
STANDARD_DEVIATION 12.492 • n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Bipolar Diagnosis
BP 1
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Bipolar Diagnosis
BP 2
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Bipolar Diagnosis
BP NOS
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms
Outcome measures
| Measure |
Pioglitazone
n=17 Participants
Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
Placebo
n=20 Participants
Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
|---|---|---|
|
Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
|
31.4 units on a scale
Standard Error 3.0
|
24.3 units on a scale
Standard Error 2.7
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=17 participants at risk
Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
Placebo
n=20 participants at risk
Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
|
|---|---|---|
|
General disorders
Headache
|
5.9%
1/17 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Confusion
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Hot Flashes
|
5.9%
1/17 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
5.9%
1/17 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/20
|
|
Cardiac disorders
Shortness of Breath
|
5.9%
1/17 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.9%
1/17 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Dizziness
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Dry Mouth
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Hair Loss
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Increased Thirst
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Stomach Upset
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Tremor
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
0.00%
0/17
|
5.0%
1/20 • Number of events 1
|
Additional Information
Carla Conroy, MPH
Univeristy Hospitals Cleveland Medical Center
Phone: 216-844-2871
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place