Trial Outcomes & Findings for Ziprasidone in Pediatric Bipolar Disorder (NCT NCT00622739)
NCT ID: NCT00622739
Last Updated: 2019-10-22
Results Overview
The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.
COMPLETED
PHASE4
28 participants
6 weeks of treatment
2019-10-22
Participant Flow
Participant milestones
| Measure |
Ziprasidone Rapid Dose Group
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Ziprasidone Rapid Dose Group
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Ziprasidone in Pediatric Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
13.53 years
STANDARD_DEVIATION 2.62 • n=5 Participants
|
13.38 years
STANDARD_DEVIATION 2.50 • n=7 Participants
|
13.4 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks of treatmentThe Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.
Outcome measures
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
12.70 units on a scale
Standard Error 1.41
|
12.57 units on a scale
Standard Error 1.32
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentThe CDRS-R is a 17 item clinician-rated instrument used to measure severity of depressive symptoms in youth (ages 6-18). Each item is rated on a 1 to 5 or 1 to 7 point scale, with a 1 describing absence of the given symptom. The CDRS-R yields a total score from 17 to 113 with a score of 40 or greater considered to symptomatic of depression. Scores of 35-40 indicate mild depression, 29-34 is borderline and \<28 is no depression.
Outcome measures
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Children's Depression Rating Scale
|
32.56 score on a scale
Standard Error 1.44
|
29.22 score on a scale
Standard Error 1.34
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentThe CGI-S assesses clinical severity. The CGI-S is a seven point scale where 1 is the minimum value and 7 is the maximum value. Lower scores mean a better outcome. The CGI-Severity scale scores are: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Outcome measures
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Clinical Global Impressions-Severity (CGI-S) Scale
|
3.63 units on a scale
Standard Error 0.19
|
3.36 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentThe Systematic Assessment for Treatment of Emergent Events (SAFTEE) is one of the first comprehensive Adverse effects-elicitation instruments developed specifically for use in psychiatric clinical trials. The SAFTEE is a standardized method, which increases consistency of Adverse Effects data, both within and across clinical trials.It allows ratings of five levels of severity and collects information about the onset, duration, pattern, judgement of attribution of cause, and action taken by the clinician. Suggested probe questions are also provided, which the clinician can use to elicit detailed information about the AE. Furthermore, the SAFTEE requires the clinician to determine a time interval of inquiry to be used in the trial. Adverse Effects are graded as None=0, Mild=1, Moderate=2, Severe=3.
Outcome measures
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
SAFTEE (Side Effects Rating Scale)
|
0.32 units on a scale
Standard Error 0.09
|
0.46 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentAIMS is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs, such as tardive dystonia and chronic akathisia, as well as 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in three main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe).
Outcome measures
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
AIMS (Abnormal Involuntary Movement Scale)
|
0.20 units on a scale
Standard Error 0.15
|
0.32 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 6 weeks of treatmentThe BARS measures drug-induced akathisia occurring specifically with use of neuroleptic agents. It is a four-item fully anchored scale. Three items (objective akathisia, subjective awareness of restlessness, and subjective distress related to restlessness) are rated on a 4-point scale (0= normal and 9= most severe) and, the global clinical assessment of akathisia uses a 5-point scale (0= normal and 4= most severe). Total scores ranged from 0-13 with higher scores reflecting more akathisia.
Outcome measures
| Measure |
Ziprasidone Rapid Dose Group
n=13 Participants
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 Participants
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Barnes Akathisia Rating Scale (BARS)
|
0.11 units on a scale
Standard Error 0.05
|
0.06 units on a scale
Standard Error 0.04
|
Adverse Events
Ziprasidone Rapid Dose Group
Ziprasidone Slow Dose Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ziprasidone Rapid Dose Group
n=13 participants at risk
Rapid Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
Ziprasidone Slow Dose Group
n=15 participants at risk
Slow Dose Titration Group
Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
|
|---|---|---|
|
Psychiatric disorders
Dystonic Reaction
|
7.7%
1/13 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
worsening of mood and inadequate response to medicaiton
|
0.00%
0/13
|
13.3%
2/15 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place