Trial Outcomes & Findings for Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia (NCT NCT00712270)
NCT ID: NCT00712270
Last Updated: 2020-07-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
At baseline and 16 weeks
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Entire Study Population
The study was pre-maturely terminated and limited data is available for reporting, since none of the study team members currently work in the organization, and are not able to be contacted. The randomization coding is not available, therefore, results cannot be reported per-Arm.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
|
7
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Overall Study
NOT COMPLETED
|
14
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Reasons for withdrawal
| Measure |
Entire Study Population
The study was pre-maturely terminated and limited data is available for reporting, since none of the study team members currently work in the organization, and are not able to be contacted. The randomization coding is not available, therefore, results cannot be reported per-Arm.
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|---|---|
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Overall Study
Withdrawal by Subject
|
11
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Overall Study
Screen Failure
|
3
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Baseline Characteristics
Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At baseline and 16 weeksPopulation: Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.
Outcome measures
Outcome data not reported
PRIMARY outcome
Population: Limited data only available for 8 of 21 patients
Information regarding the Outcome Measure being a Primary or Secondary, is unavailable.
Outcome measures
| Measure |
Standard of Care
n=8 Participants
Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.
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Drug: Aripiprazole
n=8 Participants
Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care.
Aripiprazole: Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
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Risperidone
Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.
Risperidone: Target Dose = 2mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
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|---|---|---|---|
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QTc Measurement
|
381 milliseconds
Interval 350.0 to 412.0
|
389 milliseconds
Interval 354.0 to 505.0
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—
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SECONDARY outcome
Timeframe: 7 visits over 16 weeksPopulation: Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.
Outcome measures
Outcome data not reported
Adverse Events
Entire Study Population
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Entire Study Population
n=21 participants at risk
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study.
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|---|---|
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Reproductive system and breast disorders
Decreased sexual arousal
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Renal and urinary disorders
Increased urination
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Reproductive system and breast disorders
Elevated serum HCG
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Reproductive system and breast disorders
Post-procedure vaginal bleed
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Renal and urinary disorders
Urinalysis abnormalities
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Reproductive system and breast disorders
Delayed orgasm
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Gastrointestinal disorders
Cecal polyps
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Musculoskeletal and connective tissue disorders
Leg cramps
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Musculoskeletal and connective tissue disorders
Tooth extraction
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Musculoskeletal and connective tissue disorders
Weight gain
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Nervous system disorders
Daytime sleepiness
|
33.3%
7/21 • Number of events 7
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Nervous system disorders
Akinesia
|
19.0%
4/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Nervous system disorders
Insomnia
|
28.6%
6/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Nervous system disorders
Headache
|
9.5%
2/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Nervous system disorders
Akathisia
|
4.8%
1/21 • Number of events 3
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Cardiac disorders
Lightheadedness
|
33.3%
7/21 • Number of events 7
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
General disorders
Dry mouth
|
38.1%
8/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
General disorders
Sialorrhea
|
14.3%
3/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
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Respiratory, thoracic and mediastinal disorders
Tonsilitis
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
9.5%
2/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.5%
2/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
4/21 • Number of events 4
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
Decreased appetite
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
Emesis
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
Increased appetite
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 2
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
GI distress (indigestion and cramping)
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Gastrointestinal disorders
GERD (increased symptoms)
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
General disorders
Fever
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
General disorders
Claustrophobia
|
4.8%
1/21 • Number of events 4
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Skin and subcutaneous tissue disorders
Increased sweating
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin and Hematocrit
|
4.8%
1/21
Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for AEs is not available.
|
Additional Information
Manager, Research Operations and Regulatory Compliance
Kettering Health Network
Phone: 937-395-8367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place