Trial Outcomes & Findings for Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents (NCT NCT01731119)

NCT ID: NCT01731119

Last Updated: 2017-06-14

Results Overview

Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Flexible Dose Latuda© Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents

Baseline characteristics by cohort

Measure	Flexible Dose Latuda© n=9 Participants Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.
Age, Continuous	11.4 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.

Outcome measures

Measure

Flexible Dose Latuda© n=9 Participants Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Change in Weight

0.70 lbs Interval -5.29 to 6.69

SECONDARY outcome

Timeframe: 12 weeks

Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.

Outcome measures

Measure

Flexible Dose Latuda© n=9 Participants Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Proportion of Participants Completing Treatment

7 Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.

Outcome measures

Measure

Flexible Dose Latuda© n=9 Participants Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Changes in Efficacy Measures

-14 units on a scale Interval -42.76 to 14.76

SECONDARY outcome

Timeframe: Baseline to12 weeks

Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.

Outcome measures

Measure

Flexible Dose Latuda© n=9 Participants Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Number of Participants Experiencing Side Effects

3 Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).

Outcome measures

Measure

Flexible Dose Latuda© n=9 Participants Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Overall Clinical Improvement

2.67 units on a scale Standard Deviation 1.32

Adverse Events

Flexible Dose Latuda©

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Flexible Dose Latuda© n=9 participants at risk Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant. Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.

Gastrointestinal disorders Nausea

33.3% 3/9 • Number of events 3

Additional Information

Dr. Linmarie Sikich

UNC-Chapel Hill

Email: linmarie_sikich@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place