Trial Outcomes & Findings for Oculomotor and Spatial Cognition Deficits in Schizophrenia (NCT NCT00931996)

Results Overview

Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2013-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Antipsychotic Antipsychotic treatment
Overall Study STARTED	12
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oculomotor and Spatial Cognition Deficits in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antipsychotic n=12 Participants Antipsychotic treatment
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	22.3 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Completers

Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.

Outcome measures

Outcome measures
Measure	Antipsychotic n=5 Participants Antipsychotic treatment
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.	7.4 units on a scale Standard Deviation 12.9

Adverse Events

Antipsychotic

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	Antipsychotic n=12 participants at risk Antipsychotic treatment
Nervous system disorders EPS	16.7% 2/12 • Number of events 2

Additional Information

Dr. Jeffrey Bishop

Ullinois

Phone: 312-413-3495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place