| Primary | Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16 | Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol. | Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available. | Posted | | Mean | Standard Error | percent change | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00010.06± 4.35
- OG001-2.3± 3.85
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16 | ANCOVA | ANCOVA model: log of on-treatment to baseline ratio = log of baseline value, treatment, previous antipsychotic. | | | Mean Difference (Final Values) | -11.28 | | | 2-Sided | 95 | -19.14 | -2.66 | | | Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1. | No | Superiority or Other | |
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| Secondary | Number of Participants Remaining on Metabolic Syndrome at Week 16 | Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study. | LOCF, Safety Sample For handling missing values, the metabolic syndrome is assumed to be ongoing unless there is enough data to support the resolution of the metabolic syndrome. | Posted | | Number | | participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16 | Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides. | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Mean Change From Baseline for Fasting Glucose Levels Through Week 16 | | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Mean Change From Baseline in Body Weight Through Week 16 | | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Median Change From Baseline in Body Mass Index (BMI) Through Week 16 | | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16 | A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement. | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16 | The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120. | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8,Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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| Secondary | Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16 | IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration. | This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions. | Posted | | | | | | Baseline, Week 4, Week 8, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Control Group | Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator's judgment. Participants were treated for 16 weeks. | | OG001 | Aripiprazole | Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks. |
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