Trial Outcomes & Findings for Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance (NCT NCT00835120)
NCT ID: NCT00835120
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
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Week 0 - Week 8
Results posted on
2017-01-26
Participant Flow
Participant milestones
| Measure |
Pioglitazone
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Pioglitazone
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=34 Participants
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
|
Gender
Female
|
19 Participants
n=93 Participants
|
|
Gender
Male
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Bipolar Subtype
Bipolar 1
|
27 participants
n=93 Participants
|
|
Bipolar Subtype
Bipolar 2
|
5 participants
n=93 Participants
|
|
Bipolar Subtype
Bipolar not otherwise specified
|
2 participants
n=93 Participants
|
|
Age of depression onset
|
17.8 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
|
Age of mania/hypomania onset
|
23.5 years
STANDARD_DEVIATION 19.2 • n=93 Participants
|
|
Age first treated for depression
|
34.7 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
|
Age first treated for mania/hypomania
|
40.8 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
|
Duration of mood state
|
315.5 days
STANDARD_DEVIATION 331.6 • n=93 Participants
|
|
Number of prior hospitalizations
|
2 hospitalizations
STANDARD_DEVIATION 4.0 • n=93 Participants
|
|
Number of prior suicide attempts
|
1.2 suicide attempts
STANDARD_DEVIATION 2.0 • n=93 Participants
|
|
Employed
Yes
|
12 participants
n=93 Participants
|
|
Employed
No
|
22 participants
n=93 Participants
|
|
Medication treatment failures during current episode
>=2 mood stabilizers (MS) or a MS + antidepressant
|
26 participants
n=93 Participants
|
|
Medication treatment failures during current episode
>=4 mood stabilizers or antidepressant
|
15 participants
n=93 Participants
|
|
Comorbid diagnoses
Generalized anxiety disorder
|
25 participants
n=93 Participants
|
|
Comorbid diagnoses
Panic disorder
|
11 participants
n=93 Participants
|
|
Comorbid diagnoses
Post-traumatic stress disorder
|
12 participants
n=93 Participants
|
|
Comorbid diagnoses
Obsessive-compulsive disorder
|
5 participants
n=93 Participants
|
|
Comorbid diagnoses
Alcohol use disorder, lifetime
|
19 participants
n=93 Participants
|
|
History of physical abuse
Yes
|
10 participants
n=93 Participants
|
|
History of physical abuse
No
|
24 participants
n=93 Participants
|
|
History of verbal abuse
Yes
|
14 participants
n=93 Participants
|
|
History of verbal abuse
No
|
20 participants
n=93 Participants
|
|
History of sexual abuse
Yes
|
9 participants
n=93 Participants
|
|
History of sexual abuse
No
|
25 participants
n=93 Participants
|
|
Metabolic syndrome
Yes
|
32 participants
n=93 Participants
|
|
Metabolic syndrome
No
|
2 participants
n=93 Participants
|
|
Insulin resistance
Yes
|
30 participants
n=93 Participants
|
|
Insulin resistance
No
|
4 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 0 - Week 8Inventory 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
Outcome measures
| Measure |
Pioglitazone
n=34 Participants
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
|
-16.5 units on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Week 0 - Week 8The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome
Outcome measures
| Measure |
Pioglitazone
n=34 Participants
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
|
-7.1 units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Week 0 - Week 8A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.
Outcome measures
| Measure |
Pioglitazone
n=34 Participants
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
|
13 participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 8A participant is considered in remission if their total score on the MADRS is \> 7, their total score on the QIDS-SR16 \> 6 and/or their total score on the IDS-CR is \> 12 at Week 8.
Outcome measures
| Measure |
Pioglitazone
n=34 Participants
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
|
8 participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 8The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Outcome measures
| Measure |
Pioglitazone
n=34 Participants
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
|
-1.9 units on a scale
Standard Error 0.3
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=34 participants at risk
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
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.
|
|---|---|
|
General disorders
Dizziness
|
11.8%
4/34
|
|
Psychiatric disorders
Irritability
|
11.8%
4/34
|
|
General disorders
Increased Appetite
|
11.8%
4/34
|
|
General disorders
Peripheral Edema
|
11.8%
4/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place