Trial Outcomes & Findings for Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia (NCT NCT00149734)
NCT ID: NCT00149734
Last Updated: 2021-08-13
Results Overview
P50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes.
COMPLETED
PHASE3
8 participants
Up to 3 hours
2021-08-13
Participant Flow
Participant milestones
| Measure |
Ondansetron Followed by Placebo
Participants will take ondansetron (16mg) at one study visit, then a placebo at another study visit one week later.
|
Placebo Followed by Ondansetron
Participants will take a placebo at one study visit, then ondansetron (16mg) at another study visit one week later.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
Started Intervention 2
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
Baseline characteristics by cohort
| Measure |
All Participants
n=8 Participants
Ondansetron followed by placebo group and Placebo followed by Ondansetron group
|
|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 5.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 3 hoursP50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes.
Outcome measures
| Measure |
Ondansetron
n=8 Participants
Ondansetron (16 mg)
|
Placebo
n=8 Participants
Placebo
|
|---|---|---|
|
P50 Sensory Gating
|
41.4 percentage
Standard Deviation 39.7
|
80.2 percentage
Standard Deviation 21.3
|
PRIMARY outcome
Timeframe: Measured at Months 3 and 6Population: this outcome measure was not collected due to a change in the study design via a protocol amendment.
Outcome measures
Outcome data not reported
Adverse Events
Ondansetron
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Research Administration
University of Colorado Denver
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place