Trial Outcomes & Findings for Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia (NCT NCT00231894)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

56 participants

Primary outcome timeframe

pre-treatment and during 3 months of treatment

Results posted on

2017-12-11

Participant Flow

Recruitment at 6 U.S. sites and one site in Shanghai, China

Participant milestones

Participant milestones
Measure	Pioglitazone Pioglitazone (30-45 mg/daily) plus life-style diet education group	Placebo Placebo capsules daily plus life-style diet education group
Overall Study STARTED	31	25
Overall Study COMPLETED	30	24
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pioglitazone Pioglitazone (30-45 mg/daily) plus life-style diet education group	Placebo Placebo capsules daily plus life-style diet education group
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone n=30 Participants pioglitazone	Placebo n=24 Participants placebo	Total n=54 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 9.06 • n=5 Participants	48.5 years STANDARD_DEVIATION 10.17 • n=7 Participants	47.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	19 participants n=7 Participants	44 participants n=5 Participants
Region of Enrollment China	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: pre-treatment and during 3 months of treatment

Population: Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of triglycerides at baseline and three months followup. See table 2 of published paper given in reference for further details.

Outcome measures

Outcome measures
Measure	Pioglitazone n=25 Participants pioglitazone and life-style diet group	Placebo n=19 Participants placebo and life-style diet group
Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample	-49.65 mg/dL Standard Error 24.01	30.99 mg/dL Standard Error 26.82

PRIMARY outcome

Timeframe: pre-treatment and during 3 months of treatment

Population: Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of HDL at baseline and three months followup. See table 2 of published paper and its supplementary data paper cited in reference for further details.

serum high density lipoprotein (HDL)

Outcome measures

Outcome measures
Measure	Pioglitazone n=25 Participants pioglitazone and life-style diet group	Placebo n=19 Participants placebo and life-style diet group
Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample	4.62 mg/dL Standard Error 1.77	-2.59 mg/dL Standard Error 2.11

PRIMARY outcome

Timeframe: pretreatment and during 3 months of drug treatment

Population: Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.

Outcome measures

Outcome measures
Measure	Pioglitazone n=25 Participants pioglitazone and life-style diet group	Placebo n=19 Participants placebo and life-style diet group
Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample	0.02 mg/dL Standard Error 8.14	24.20 mg/dL Standard Error 8.63

PRIMARY outcome

Timeframe: between baseline and 3 months of study drug treatment

Population: Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.

difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment

Outcome measures

Outcome measures
Measure	Pioglitazone n=25 Participants pioglitazone and life-style diet group	Placebo n=19 Participants placebo and life-style diet group
2 Hour Glucose From Glucose Tolerance Test US Sample	-24.19 mg/dL Standard Error 17.03	15.19 mg/dL Standard Error 17.75

SECONDARY outcome

Timeframe: pre-treatment and 3 months of treatment

Population: Data is from participants at U.S. sites N=43, Pioglitazone =25, Placebo =18, who had scores of RBANS List learning at 2-hour point at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.

The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measure cognitive function in patients with schizophrenia. Range for list learning sub-score is 0 to 20 . Higher values indicate better performance. For change score (3 months -baseline) positive values indicate improved performance for this cognitive function and negative values indicate poorer performance on this cognitive function.

Outcome measures

Outcome measures
Measure	Pioglitazone n=25 Participants pioglitazone and life-style diet group	Placebo n=19 Participants placebo and life-style diet group
Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample	0.27 Units on RBANS scale Standard Error 0.41	-1.11 Units on RBANS scale Standard Error 0.44

SECONDARY outcome

Timeframe: pretreatment and during 3 months of drug treatment

Population: Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of fasting glucose at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.

Outcome measures

Outcome measures
Measure	Pioglitazone n=5 Participants pioglitazone and life-style diet group	Placebo n=5 Participants placebo and life-style diet group
Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample	-13.33 mg/dL Standard Error 11.08	-11.5 mg/dL Standard Error 3.44

SECONDARY outcome

Timeframe: pretreatment and during 3 months of drug treatment

Population: Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of triglycerides at baseline and three months followup. See published paper and its supplementary data paper cited in reference for further details.

Outcome measures

Outcome measures
Measure	Pioglitazone n=5 Participants pioglitazone and life-style diet group	Placebo n=5 Participants placebo and life-style diet group
Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample	32.56 mg/dL Standard Error 24.76	-79.12 mg/dL Standard Error 40.72

SECONDARY outcome

Timeframe: between baseline and 3 months of study drug treatment

Population: Data is from participants at china site N=10, Pioglitazone =5, Placebo =5, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.

difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment

Outcome measures

Outcome measures
Measure	Pioglitazone n=5 Participants pioglitazone and life-style diet group	Placebo n=5 Participants placebo and life-style diet group
2 Hour Glucose From Glucose Tolerance Test China Sample	-6.82 mg/dL Standard Error 21.28	-40.72 mg/dL Standard Error 21.28

SECONDARY outcome

Timeframe: pretreatment and during 3 months of drug treatment

Population: Data is from participants at china. site N=10, Pioglitazone =5, Placebo =5, who had values of HDL at baseline and three months followup. See of published paper and its supplementary data paper cited in reference for further details

Outcome measures

Outcome measures
Measure	Pioglitazone n=5 Participants pioglitazone and life-style diet group	Placebo n=5 Participants placebo and life-style diet group
Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site	6.52 mg/dL Standard Error 1.14	7.72 mg/dL Standard Error 3.37

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pioglitazone n=31 participants at risk pioglitazone	Placebo n=25 participants at risk placebo
Endocrine disorders glucose increase	0.00% 0/31	4.0% 1/25 • Number of events 1
Musculoskeletal and connective tissue disorders high CPK	3.2% 1/31 • Number of events 1	0.00% 0/25

Additional Information

Robert C. Smith MD

Nathan Kline Institute ofr Psychiatric research

Phone: 845-398-6531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place