Trial Outcomes & Findings for Ziprasidone in the Psychosis Prodrome (NCT NCT00635700)

Results Overview

Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

6 months

Results posted on

2023-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Ziprasidone ziprasidone: 20-160 mg/d	Placebo placebo: placebo
Overall Study STARTED	24	27
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	15	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ziprasidone in the Psychosis Prodrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ziprasidone n=23 Participants ziprasidone: 20-160 mg/d	Placebo n=27 Participants placebo: placebo	Total n=50 Participants Total of all reporting groups
Age, Continuous	21.9 years STANDARD_DEVIATION 4.7 • n=99 Participants	22.6 years STANDARD_DEVIATION 3.7 • n=107 Participants	22.3 years STANDARD_DEVIATION 4.2 • n=206 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	19 Participants n=107 Participants	32 Participants n=206 Participants
Region of Enrollment United States	23 participants n=99 Participants	27 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: In another case assigned to active ziprasidone, ratings conducted at a follow-up conversion visit suggested retrospectively that the patient had been already psychotic prior to enrollment. The study's blinded DSMB was consulted, and in a split 4-2 vote recommended retaining the patient as randomized in the primary analysis.

Conversion to psychosis according to the Structured Interview for Psychosis-risk Syndromes (SIPS) require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.

Outcome measures

Outcome measures
Measure	Ziprasidone n=23 Participants ziprasidone: 20-160 mg/d	Placebo n=27 Participants placebo: placebo
Conversion to Psychosis	1 participants	2 participants

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: All subjects who received allocated intervention

The Scale of Psychosis-risk Symptoms, a 19-item scale with items scored 0-6. Positive Symptom scores on the SOPS in the 1 to 2 range are considered non-prodromal. Scores of 6 are considered psychotic. Scores in the 3 to 5 range are considered at the clinical high risk level. Minimum value 0. Maximum value 114. Higher score means worse outcome.

Outcome measures

Outcome measures
Measure	Ziprasidone n=23 Participants ziprasidone: 20-160 mg/d	Placebo n=27 Participants placebo: placebo
Change in Scale of Psychosis-risk Symptoms Total Score	-0.271 scores on a scale Interval -0.693 to 0.152	0 scores on a scale Interval 0.0 to 0.0

Adverse Events

Ziprasidone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ziprasidone n=24 participants at risk ziprasidone: 20-160 mg/d	Placebo n=27 participants at risk placebo: placebo
Cardiac disorders EKG abnormalities	4.2% 1/24 • Number of events 1	7.4% 2/27 • Number of events 2

Additional Information

Scott W. Woods, M.D.

Yale University

Phone: 203-974-7038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place