Trial Outcomes & Findings for Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders (NCT NCT00221403)

Last Updated: 2020-10-20

Results Overview

Young Mania Rating Scale (YMRS) total scores change from baseline by treatment group. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

46 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Risperidone Subjects only taking Risperidone.	Valproate Subjects taking Valproate only.	Placebo Subjects taking Placebo only.
Overall Study STARTED	18	21	7
Overall Study COMPLETED	16	16	7
Overall Study NOT COMPLETED	2	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Risperidone Subjects only taking Risperidone.	Valproate Subjects taking Valproate only.
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	3
Overall Study Lack of Efficacy	0	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperidone n=18 Participants Subjects taking Risperidone only.	Valproate n=21 Participants Subjects taking Valproate only.	Placebo n=7 Participants Subjects taking Placebo only.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	18 Participants n=5 Participants	21 Participants n=7 Participants	7 Participants n=5 Participants	46 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	5.31 years STANDARD_DEVIATION 1.3 • n=5 Participants	6.03 years STANDARD_DEVIATION 1.3 • n=7 Participants	5.19 years STANDARD_DEVIATION 1.0 • n=5 Participants	5.51 years STANDARD_DEVIATION 1.25 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	21 participants n=7 Participants	7 participants n=5 Participants	46 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Subjects were male or female outpatient subjects, 3.0-7 years,11 months of age, with bipolar I disorder, mixed or manic episode, psychotic or nonpsychotic, according to DSM IV-TR criteria, with a score ‡ 20 (considered to be moderate severity) on the Young Mania Rating Scale (YMRS) at the time of randomization.

Outcome measures

Outcome measures
Measure	Valproate (VPA) n=21 Participants VPA was administered in liquid form, matched for taste and color with the placebo. Medication was administered in a double-blinded manner on a twice-daily basis. Patients randomized to VPA were administered an initial dose of 10 mg/kg/day on a twice daily schedule beginning on day 0. VPA levels were adjusted to achieve a blood level of 80-100 lg/mL. An independent, unblinded study psychiatrist adjusted VPA doses to achieve a therapeutic level Valproate Oral Solution: liquid, BID dosing.	Risperidone n=18 Participants Risperidone was administered in liquid form matched for taste and color to the placebo. Medications were administered in a double-blinded manner on a twice-daily basis. Risperidone oral solution: liquid, BID dosing.	Placebo n=7 Participants The placebo was administered in liquid form, matched for taste and color with the active comparator. Placebo: liquid, BID dosing.
YMRS	10 score on a scale Standard Deviation 2.46	18.82 score on a scale Standard Deviation 1.55	4.29 score on a scale Standard Deviation 3.56

Adverse Events

Risperidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Valproate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Risperidone n=18 participants at risk Subjects only taking Risperidone.	Valproate n=21 participants at risk Subjects taking Valproate only.	Placebo n=7 participants at risk Subjects taking Placebo only.
General disorders nausea	0.00% 0/18 • 6 weeks AEs were assessed with a checklist (SEFCA), rated on a scale of ''not present'' to ''mild, does not interfere with functioning,'' ''moderate, some interference with functioning,'' and ''severe, functioning is significantly impaired because of side effects.'' A significant AE was identified if not been present at baseline, but was reported during the course of the study, or if it had been present at baseline, but its severity was increased by at least 1 point on the scale during the study.	4.8% 1/21 • Number of events 1 • 6 weeks AEs were assessed with a checklist (SEFCA), rated on a scale of ''not present'' to ''mild, does not interfere with functioning,'' ''moderate, some interference with functioning,'' and ''severe, functioning is significantly impaired because of side effects.'' A significant AE was identified if not been present at baseline, but was reported during the course of the study, or if it had been present at baseline, but its severity was increased by at least 1 point on the scale during the study.	0.00% 0/7 • 6 weeks AEs were assessed with a checklist (SEFCA), rated on a scale of ''not present'' to ''mild, does not interfere with functioning,'' ''moderate, some interference with functioning,'' and ''severe, functioning is significantly impaired because of side effects.'' A significant AE was identified if not been present at baseline, but was reported during the course of the study, or if it had been present at baseline, but its severity was increased by at least 1 point on the scale during the study.

Additional Information

Robert Kowatch, MD, PhD

Ohio State Medical Center/Nationwide Children's Hospital

Phone: (614) 355-2872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place