Trial Outcomes & Findings for Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes (NCT NCT00288353)

NCT ID: NCT00288353

Last Updated: 2025-10-02

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

24 weeks

Results posted on

2025-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Aripiprazole (Abilify) aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Overall Study STARTED	25	23
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole (Abilify) aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Overall Study Lack of Efficacy	2	2
Overall Study Withdrawal by Subject	5	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.	Total n=48 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 8.5 • n=25 Participants	45.5 years STANDARD_DEVIATION 9.4 • n=23 Participants	44.9 years STANDARD_DEVIATION 8.9 • n=48 Participants
Sex/Gender, Customized Self-Reported Gender · Male	9 Participants n=25 Participants	10 Participants n=23 Participants	19 Participants n=48 Participants
Sex/Gender, Customized Self-Reported Gender · Female	16 Participants n=25 Participants	13 Participants n=23 Participants	29 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Hypertension, number Participants with hypertension	13 Participants n=25 Participants	3 Participants n=23 Participants	16 Participants n=48 Participants
Hypertension, number Participants without hypertension	12 Participants n=25 Participants	20 Participants n=23 Participants	32 Participants n=48 Participants
Type 2 Diabetes, number Participants with Type 2 Diabetes	4 Participants n=25 Participants	5 Participants n=23 Participants	9 Participants n=48 Participants
Type 2 Diabetes, number Participants without Type 2 Diabetes	21 Participants n=25 Participants	18 Participants n=23 Participants	39 Participants n=48 Participants
Diagnosis of schizophrenia (SCH) and schizoaffective disorder (SCHAF) or bipolar disorder number schizophrenia (SCH) or schizoaffective disorder (SCHAF)	14 Participants n=25 Participants	9 Participants n=23 Participants	23 Participants n=48 Participants
Diagnosis of schizophrenia (SCH) and schizoaffective disorder (SCHAF) or bipolar disorder number bipolar disorder	11 Participants n=25 Participants	14 Participants n=23 Participants	25 Participants n=48 Participants
Positive and Negative Syndrome Scale (PANSS) Total Score	61.3 units on a scale STANDARD_DEVIATION 2.2 • n=25 Participants	61.0 units on a scale STANDARD_DEVIATION 2.2 • n=23 Participants	61.15 units on a scale STANDARD_DEVIATION 2.2 • n=48 Participants
Positive and Negative Syndrome Scale (PANSS) Positive Score	14.2 units on a scale STANDARD_DEVIATION 0.7 • n=25 Participants	14.2 units on a scale STANDARD_DEVIATION 0.7 • n=23 Participants	14.2 units on a scale STANDARD_DEVIATION 0.7 • n=48 Participants
Positive and Negative Syndrome Scale (PANSS) Negative Score	15.3 units on a scale STANDARD_DEVIATION 0.7 • n=25 Participants	15.2 units on a scale STANDARD_DEVIATION 0.6 • n=23 Participants	15.25 units on a scale STANDARD_DEVIATION 0.65 • n=48 Participants
Positive and Negative Syndrome Scale (PANSS) Cognitive Score	6.7 units on a scale STANDARD_DEVIATION 0.4 • n=25 Participants	6.6 units on a scale STANDARD_DEVIATION 0.4 • n=23 Participants	6.65 units on a scale STANDARD_DEVIATION 0.4 • n=48 Participants
Drug taken prior to enrollment Olazapine	4 Participants n=25 Participants	4 Participants n=23 Participants	8 Participants n=48 Participants
Drug taken prior to enrollment Quetiapine	10 Participants n=25 Participants	9 Participants n=23 Participants	19 Participants n=48 Participants
Drug taken prior to enrollment Risperidone	8 Participants n=25 Participants	7 Participants n=23 Participants	15 Participants n=48 Participants
Drug taken prior to enrollment Typical neuroleptics	2 Participants n=25 Participants	1 Participants n=23 Participants	3 Participants n=48 Participants
Drug taken prior to enrollment Mood stabilizer only	1 Participants n=25 Participants	2 Participants n=23 Participants	3 Participants n=48 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio Baseline	8.1 (mg/dL)/(mg/dL) Standard Error 0.7	8.2 (mg/dL)/(mg/dL) Standard Error 0.6
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio 6 weeks	4.9 (mg/dL)/(mg/dL) Standard Error 0.7	4.7 (mg/dL)/(mg/dL) Standard Error 0.7
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio 12 weeks	4.8 (mg/dL)/(mg/dL) Standard Error 0.7	5.6 (mg/dL)/(mg/dL) Standard Error 0.7
Triglyceride/High-density Lipoprotein (TG/HDL) Ratio 24 weeks	5.7 (mg/dL)/(mg/dL) Standard Error 0.9	5.2 (mg/dL)/(mg/dL) Standard Error 0.7

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Weight Baseline	216.8 lbs Standard Error 2.4	216.7 lbs Standard Error 2.2
Weight 6 weeks	211.8 lbs Standard Error 2.5	208.8 lbs Standard Error 2.3
Weight 12 weeks	211.2 lbs Standard Error 2.6	209.4 lbs Standard Error 2.5
Weight 24 weeks	210.9 lbs Standard Error 3.0	207.1 lbs Standard Error 2.5

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Body Mass Index (BMI) Baseline	35.5 kg/m^2 Standard Error 0.4	35.5 kg/m^2 Standard Error 0.4
Body Mass Index (BMI) 6 weeks	34.7 kg/m^2 Standard Error 0.4	34.1 kg/m^2 Standard Error 0.4
Body Mass Index (BMI) 12 weeks	34.6 kg/m^2 Standard Error 0.4	34.3 kg/m^2 Standard Error 0.5
Body Mass Index (BMI) 24 weeks	34.4 kg/m^2 Standard Error 0.5	33.9 kg/m^2 Standard Error 0.4

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Cholesterol Baseline	210.4 mg/DL Standard Error 8.8	211.7 mg/DL Standard Error 7.9
Cholesterol 6 Weeks	193.0 mg/DL Standard Error 9.1	203.7 mg/DL Standard Error 8.4
Cholesterol 12 Weeks	209.2 mg/DL Standard Error 9.4	193.2 mg/DL Standard Error 9.0
Cholesterol 24 Weeks	197.7 mg/DL Standard Error 10.3	85.9 mg/DL Standard Error 9.3

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
High-Density Lipoprotein (HDL) Baseline	39.7 mg/dL Standard Error 1.6	38.4 mg/dL Standard Error 1.5
High-Density Lipoprotein (HDL) 6 Weeks	42.0 mg/dL Standard Error 1.7	45.0 mg/dL Standard Error 1.6
High-Density Lipoprotein (HDL) 12 Weeks	43.5 mg/dL Standard Error 1.8	45.0 mg/dL Standard Error 1.7
High-Density Lipoprotein (HDL) 24 Weeks	43.5 mg/dL Standard Error 2.1	42.3 mg/dL Standard Error 1.8

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Aripiprazole (Abilify) n=25 Participants aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.	Ziprasidone (Geodon) n=23 Participants ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.
Triglyceride (TG) Baseline	306.1 mg/dL Standard Error 27.1	303.5 mg/dL Standard Error 25.1
Triglyceride (TG) 6 Weeks	204.3 mg/dL Standard Error 29.7	202.5 mg/dL Standard Error 27.1
Triglyceride (TG) 12 Weeks	198.8 mg/dL Standard Error 29.7	228.5 mg/dL Standard Error 28.8
Triglyceride (TG) 24 Weeks	238.7 mg/dL Standard Error 36.3	208.1 mg/dL Standard Error 30.8

Adverse Events

Aripiprazole (Abilify)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ziprasidone (Geodon)

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. Herbert Meltzer

Northwestern University

Phone: (312) 503-0309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place