Trial Outcomes & Findings for SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia (NCT NCT01760889)
NCT ID: NCT01760889
Last Updated: 2021-06-22
Results Overview
TERMINATED
PHASE3
1 participants
Baseline and 26 weeks
2021-06-22
Participant Flow
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Participant milestones
| Measure |
SPD489 Low Dose Range
SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
|
SPD489 High Dose Range
SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
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Placebo
Placebo: One capsule a day for 26 weeks
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Overall Study
STARTED
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0
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0
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0
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Overall Study
COMPLETED
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0
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 26Population: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Outcome measures
Outcome data not reported
Adverse Events
SPD489 Low Dose Range
SPD489 High Dose Range
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER