Trial Outcomes & Findings for Pioglitazone in Patients With Mood Disorders (NCT NCT01559857)

Results Overview

The HDRS-21 was used to screen for unremitted depression. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity. Unremitted depression is characterized by a score of ≥7. The HDRS-21 scores at baseline are shown in the data table below.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

Baseline

Results posted on

2017-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone 50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone. Pioglitazone: 30mg once daily for 12 weeks	Sugar Pill 50% of participants will be randomized to 12 weeks of treatment with placebo pill. Sugar Pill: Placebo
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pioglitazone in Patients With Mood Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone n=19 Participants 50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone. Pioglitazone: 30mg once daily for 12 weeks	Sugar Pill n=18 Participants 50% of participants will be randomized to 12 weeks of treatment with placebo pill. Sugar Pill: Placebo	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants	18 Participants n=107 Participants	37 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	49.42 years STANDARD_DEVIATION 15.11 • n=99 Participants	43.28 years STANDARD_DEVIATION 11.80 • n=107 Participants	46.35 years STANDARD_DEVIATION 13.45 • n=206 Participants
Sex: Female, Male Female	15 Participants n=99 Participants	14 Participants n=107 Participants	29 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment United States	19 participants n=99 Participants	18 participants n=107 Participants	37 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline

The HDRS-21 was used to screen for unremitted depression. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity. Unremitted depression is characterized by a score of ≥7. The HDRS-21 scores at baseline are shown in the data table below.

Outcome measures

Outcome measures
Measure	Pio - IS n=9 Participants Participants who received pioglitazone and were insulin sensitive.	Placebo - IS n=8 Participants Participants who received placebo and were insulin sensitive.	Pio - IR n=10 Participants Participants who received pioglitazone and were insulin resistant.	Placebo - IR n=10 Participants Participants who received the sugar pill and were insulin resistant.
Hamilton Depression Rating Scale at Baseline	15.22 units on a scale Standard Deviation 2.64	13.67 units on a scale Standard Deviation 1.51	19.22 units on a scale Standard Deviation 7.26	13.25 units on a scale Standard Deviation 4.91

SECONDARY outcome

Timeframe: Baseline

The fasting plasma insulin measurements taken at baseline are shown in the data table below.

Outcome measures

Outcome measures
Measure	Pio - IS n=9 Participants Participants who received pioglitazone and were insulin sensitive.	Placebo - IS n=8 Participants Participants who received placebo and were insulin sensitive.	Pio - IR n=10 Participants Participants who received pioglitazone and were insulin resistant.	Placebo - IR n=10 Participants Participants who received the sugar pill and were insulin resistant.
Fasting Insulin Measurements at Baseline	10.61 uIU/mL Standard Deviation 2.49	9.18 uIU/mL Standard Deviation 3.98	13.98 uIU/mL Standard Deviation 6.35	14.12 uIU/mL Standard Deviation 4.42

SECONDARY outcome

Timeframe: 12 weeks

The HDRS-21 was administered at baseline and at the end of 12 weeks, and the mean difference between the two time points was calculated. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity.

Outcome measures

Outcome measures
Measure	Pio - IS n=9 Participants Participants who received pioglitazone and were insulin sensitive.	Placebo - IS n=8 Participants Participants who received placebo and were insulin sensitive.	Pio - IR n=10 Participants Participants who received pioglitazone and were insulin resistant.	Placebo - IR n=10 Participants Participants who received the sugar pill and were insulin resistant.
Change in HDRS-21: From Baseline to 12 Weeks	-4.45 units on a scale Standard Deviation 2.34	-3.57 units on a scale Standard Deviation 1.9	-1.71 units on a scale Standard Deviation 3.55	-3.57 units on a scale Standard Deviation 5.77

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Natalie Rasgon

Stanford University

Phone: 6507249694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place