Safety and Efficacy of Ziprasidone in Children and Adoles... | NCT00257166

Safety and Efficacy of Ziprasidone in Children and Adoles... | NCT00257166 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Ziprasidone oral capsules	Experimental		Drug: Ziprasidone oral capsules
Placebo	Placebo Comparator		Drug: placebo oral capsules

Name	Type	Description	Arm Group Labels	Other Names
Ziprasidone oral capsules	Drug	Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.	Ziprasidone oral capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.	Baseline, Week 4

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Scottsdale	Arizona	85251	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24111980	Derived	Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG00018 subjects FG00113 subjects
Laboratory abnormality		FG0001 subjects FG0010 subjects
Lost to Follow-up		FG0008 subjects FG0011 subjects
Withdrawal by Subject		FG0009 subjects FG0012 subjects
Other		FG00016 subjects FG00121 subjects
Randomized, but not treated		FG0001 subjects FG0010 subjects

Arm/Group Information

ID	Title	Description
BG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
BG001	Placebo	Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

10 to 13 years

Title	Measurements
	BG00074 BG00135 BG002109

14 to 17 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00141 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4

YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.

Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (>=) 1 dose of study medication (ziprasidone or placebo) and had >=1 post-baseline visit. Here, 'n' signifies those participants who were available for this measure at given time points for each group.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 4

ID	Title	Description
OG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
OG001	Placebo	Placebo matched to ziprasidone capsule orally twice daily up to Week 4.

Units	Counts
Participants	OG000143 OG00186

Title

Denominators

Categories

Baseline (n=143,86)

Title	Measurements
	OG00026.2± 6.6 OG00127.0± 6.6

Change at Week 4 (n=97,51)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA		0.0005		Least squares (LS) mean difference	-5.22	Standard Error of the Mean	1.48	2-Sided	95	-8.12	-2.31					Superiority or Other (legacy)

Secondary

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3

ITT population. 'N' (number of participants analyzed) signifies those participants who were available for this measure. 'n' signifies those participants who were available for this measure at given time points for each group respectively.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 1, 2, 3

ID	Title	Description
OG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
OG001

Secondary

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).

ITT population. Here, 'n' signifies those participants who were available for this measure at given time points for each group respectively.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 1, 2, 3, 4

ID	Title	Description
OG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
OG001	Placebo	Placebo matched to ziprasidone capsule orally twice daily up to Week 4.

Secondary

Clinical Global Impression - Improvement (CGI-I) Score

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were available for this measure at given time points for each group respectively.

Posted

Mean

Standard Deviation

units on a scale

Week 1, 2, 3, 4

ID	Title	Description
OG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
OG001	Placebo	Placebo matched to ziprasidone capsule orally twice daily up to Week 4.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ziprasidone	Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.			6	149	128	149
EG001	Placebo	Placebo matched to ziprasidone capsule orally twice daily up to Week 4.			7	88	42	88

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dystonia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0010 affected88 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0010 affected88 at risk
Viral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0010 affected88 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0013 affected88 at risk
Liver function test abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0010 affected88 at risk
Mania	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0010 affected88 at risk
Aggression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0012 affected88 at risk
Hypersexuality	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected149 at risk EG0010 affected88 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected149 at risk EG0011 affected88 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected149 at risk EG0011 affected88 at risk
Hallucination	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected149 at risk EG0011 affected88 at risk
Paranoia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected149 at risk EG0011 affected88 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected149 at risk EG0011 affected88 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected149 at risk EG0013 affected88 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00021 affected149 at risk EG0016 affected88 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00012 affected149 at risk EG0011 affected88 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00023 affected149 at risk EG0016 affected88 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0008 affected149 at risk EG0010 affected88 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0006 affected149 at risk EG0015 affected88 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected149 at risk EG0010 affected88 at risk
Akathisia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected149 at risk EG0011 affected88 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00019 affected149 at risk EG0012 affected88 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00033 affected149 at risk EG00119 affected88 at risk
Sedation	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00049 affected149 at risk EG0015 affected88 at risk
Somnolence	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00037 affected149 at risk EG0017 affected88 at risk
Tremor	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected149 at risk EG0010 affected88 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG00014 affected149 at risk EG0013 affected88 at risk
Restlessness	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected149 at risk EG0011 affected88 at risk

Title

Denominators

Categories

Change at Week 1 (n=131,85)

Title	Measurements
	OG000-9.3± 7.5 OG001-6.3± 7.1

Change at Week 2 (n=120,81)

Title	Measurements
	OG000-11.5± 8.7 OG001-8.1± 7.9

Change at Week 3 (n=108,65)

Title	Measurements
	OG000-13.0± 8.1 OG001-9.0± 7.3

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	0.0006	LS mean difference	-3.2545	Standard Error of the Mean	0.9422	2-Sided	95	-5.1045	-1.4046	Superiority or Other (legacy)
OG000 OG001	Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	0.0117	LS mean difference	-3.5857	Standard Error of the Mean	1.4184	2-Sided	95	-6.3705	-0.8009	Superiority or Other (legacy)
OG000 OG001	Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	0.0047	LS mean difference	-4.8665	Standard Error of the Mean	1.7154	2-Sided	95	-8.2345	-1.4985	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline (n=143,86)

Title	Measurements
	OG0004.5± 0.7 OG0014.5± 0.7

Change at Week 1 (n=131,85)

Title	Measurements
	OG000-0.9± 0.8 OG001-0.5± 0.9

Change at Week 2 (n=120,82)

Title	Measurements
	OG000-1.1± 1.0 OG001-0.6± 0.9

Change at Week 3 (n=108,65)

Title	Measurements
	OG000-1.3± 1.0 OG001-0.7± 1.0

Change at Week 4 (n=96,51)

Title	Measurements
	OG000-1.4± 1.1 OG001-0.9± 0.9

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	0.0002	LS mean difference	-0.3754	Standard Error of the Mean	0.0989	2-Sided	95	-0.5696	-0.1812	Superiority or Other (legacy)
OG000 OG001	Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	<0.0001	LS mean difference	-0.5596	Standard Error of the Mean	0.1355	2-Sided	95	-0.8256	-0.2936	Superiority or Other (legacy)
OG000 OG001	Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	<0.0001	LS mean difference	-0.6798	Standard Error of the Mean	0.1643	2-Sided	95	-1.0024	-0.3572	Superiority or Other (legacy)
OG000 OG001	Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.	ANCOVA	0.0001	LS mean difference	-0.6884	Standard Error of the Mean	0.1761	2-Sided	95	-1.0342	-0.3426	Superiority or Other (legacy)

Title

Denominators

Categories

Week 1 (n=132,85)

Title	Measurements
	OG0002.8± 0.9 OG0013.4± 0.9

Week 2 (n=120,82)

Title	Measurements
	OG0002.5± 1.1 OG0013.2± 1.1

Week 3 (n=108,65)

Title	Measurements
	OG0002.4± 1.0 OG0013.1± 1.3

Week 4 (n=96,51)

Title	Measurements
	OG0002.3± 1.0 OG0012.8± 1.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.	ANCOVA		0.0004		LS mean difference	-0.76	Standard Error of the Mean	0.21	2-Sided	95	-1.18	-0.34					Superiority or Other (legacy)

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders