Trial Outcomes & Findings for Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade (NCT NCT00225498)

Results Overview

California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome. The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

3 months

Results posted on

2015-09-10

Participant Flow

10 schizophrenia patients who met nonresponse criteria

The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.

Participant milestones

Participant milestones
Measure	Ziprasidone ziprasidone target dose is 160 mg/day
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=35 Participants Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	34.2834 years STANDARD_DEVIATION 8.83101 • n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Region of Enrollment United States	35 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.

California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome. The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.

Outcome measures

Outcome measures
Measure	Ziprasidone n=10 Participants ziprasidone target dose is 160 mg/day
Working Memory	44.8 units on a scale Standard Deviation 11.8

Adverse Events

Ziprasidone

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

Anil K. Malhotra, MD

Feinstein Institute for Medical Research, Zucker Hillside Hospital

Phone: 718-470-8012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place