Trial Outcomes & Findings for Optimizing Response in Psychosis Study (NCT NCT00314327)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

13 weeks

Results posted on

2018-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Long-acting Injectable Risperidone One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection. long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Long-acting Injectable Risperidone One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection. long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Optimizing Response in Psychosis Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Long-acting Injectable Risperidone n=1 Participants One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection. long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Age, Continuous	19 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

Population: Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized.

Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized. The negative symptoms that were going to be analyzed include: Affective Flattening, Alogia, Avolition /Apathy, and Anhedonia/Asociality

Outcome measures

Outcome data not reported

Adverse Events

Long-acting Injectable Risperidone

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

Delbert Robinson, M.D.

NSLIJ

Phone: 718-470-8195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place