Extension Study Evaluating The Safety And Tolerability Of... | NCT03768726

NCT03768726

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ziprasidone	Experimental	All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.	Drug: Ziprasidone Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ziprasidone	Drug	All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.	A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Laboratory Abnormalities	Hemoglobin (Hg), hematocrit, erythrocytes: <0.8lower limits of normal (LLN); platelets: <0.5LLN>1.75upper limits of normal (ULN); leukocytes (leu), glucose-fasting:<0.6LLN>1.5ULN; lymphocytes (lym), lym/leu, neutrophils (neu), neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: <0.8LLN>1.2ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: >1.2ULN; bilirubin (total, direct, indirect):>1.5ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:>3.0ULN; blood urea nitrogen, creatinine, cholesterol (total, LDL, HDL), triglycerides, Hg A1C: >1.3ULN; sodium: <0.95LLN>1.05ULN; potassium, chloride, calcium, magnesium, bicarbonate: <0.9LLLN>1.1ULN; prolactin: >1.1ULN; creatine kinase: >2.0*ULN; urobilinogen: >=1; Urine-specific gravity: <1.003>1.030, pH: <4.5 >8, glucose, protein, bilirubin, nitrite, leukocyte esterase, ketones: >=1.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Evidence of personally signed and dated informed consent document by the legal representative and an assent document by the subject .
Subjects and their legal guardians who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
The subjects must have received investigational product in Study A1281198 before entering this open label extension.
In the investigator's opinion, the subject must be likely to benefit from antipsychotic therapy .
All fertile male subjects and female subjects of childbearing potential who are sexually active and/or their legal guardians, as appropriate, must agree that a highly effective method of contraception

Exclusion Criteria

Any subjects from the preceding double blind trail who experienced a serious adverse event which required study medication to be discontinued and the subject to be withdrawn from the study. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persistent Fridericia's correction (QTcF) >480 msec or increase from baseline QTcF >60 msec) during the preceding study.
Subjects requiring any medications not allowed by the Concomitant Medication Table 12 (see "Concomitant Treatment(s)").
Subjects who require treatment with drugs that are known to consistently prolong the QT interval (see Concomitant Medication Table 12).
Subjects who are judged by the investigator as being at imminent risk of suicide.
Subjects living in the same home as another study participant or having the same caregiver during the same enrollment period (Such subjects can be enrolled in the study at different times but may not be in the study at the same time).
Subjects should be excluded or a risk assessment should be done to verify that it is safe for the subject to participate in the trial if the subject's responses on the C SSRS or other information based on the investigator's judgment indicate:
- Suicide ideation associated with actual intent and a method or plan such that a positive response ('Yes') is made on items 4 or 5 of the suicidal ideation subscale of the C SSRS; or
- Any suicide behaviors such that a determination of 'yes' is made to any of the suicide behavior items of the C SSRS.
Pregnant female subjects, breastfeeding female subjects.
Participation in other studies other than the preceding Study.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research Group of Central Florida		Orange City	Florida	32763	United States
Inova Clinical Trials and Research Centre

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36282771	Derived	Atkinson S, Bachinsky M, Raiter Y, Abreu P, Ianos C, Chappell P, Findling RL. 26-Week Open-Label Extension Study Evaluating the Safety and Tolerability of Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I Disorder (Most Recent Episode Manic). J Child Adolesc Psychopharmacol. 2022 Oct;32(8):453-458. doi: 10.1089/cap.2022.0030.
35394365

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

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight greater than or equal to (>=) 45 kilogram (kg) had a target total daily dose range of 120-160 milligram per day (mg/day) given in 2 divided doses with food. Participants with body weight less than (<) 45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 19, 2019	Mar 30, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.

Arm/Group Information

ID	Title	Description
BG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
BG001	Placebo in A1281198 Then Ziprasidone in A1281201	Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.
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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.0± 2.3 BG00114.2± 2.0 BG00214.1± 2.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG0017 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 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

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.

The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.

Posted

Count of Participants

Participants

A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
OG001	Placebo in A1281198 Then Ziprasidone in A1281201	Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.

Units	Counts
Participants	OG00010 OG00113

Title

Denominators

Categories

AEs

Title	Measurements
	OG0007 OG00112

SAEs

Title	Measurements
	OG000

Secondary

Number of Participants With Laboratory Abnormalities

Hemoglobin (Hg), hematocrit, erythrocytes: <0.8*lower limits of normal (LLN); platelets: <0.5*LLN>1.75*upper limits of normal (ULN); leukocytes (leu), glucose-fasting:<0.6*LLN>1.5*ULN; lymphocytes (lym), lym/leu, neutrophils (neu), neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: <0.8*LLN>1.2*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: >1.2*ULN; bilirubin (total, direct, indirect):>1.5*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol (total, LDL, HDL), triglycerides, Hg A1C: >1.3*ULN; sodium: <0.95*LLN>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLLN>1.1*ULN; prolactin: >1.1*ULN; creatine kinase: >2.0*ULN; urobilinogen: >=1; Urine-specific gravity: <1.003>1.030, pH: <4.5 >8, glucose, protein, bilirubin, nitrite, leukocyte esterase, ketones: >=1.

The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.

Posted

Count of Participants

Participants

A1281201: Day 1 up to 1 Week after last dose of study medication (maximum up to 27 Weeks)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Number of Participants With Physical Examination Abnormalities at Baseline and Week 26

Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia (if medically indicated), extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion.

The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study.

Posted

Count of Participants

Participants

Baseline (last measurement from A1281198), Week 26 of A1281201

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

Change from baseline in sitting and standing systolic and diastolic blood pressure in millimeter of mercury (mmHg) was reported.

The safety analysis set included all participants who took at least 1 dose of study medication in this open-label extension study. Here 'number analyzed' signifies number of participants evaluable for each specified row.

Posted

Mean

Standard Deviation

mmHg

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

Change from baseline pulse rate in beats per minute was reported in sitting and standing positions.

Posted

Mean

Standard Deviation

beats per minute

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit

Change from baseline in height and waist circumference in centimeter (cm) was reported.

Posted

Mean

Standard Deviation

Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
OG001

Secondary

Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit

Change from baseline in body weight in kilogram (kg) was reported.

Posted

Mean

Standard Deviation

Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
OG001	Placebo in A1281198 Then Ziprasidone in A1281201

Secondary

Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit

Change from baseline in BMI in kilogram per meter square (kg/m^2) was reported.

Posted

Mean

Standard Deviation

kg/m^2

Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.
OG001

Secondary

Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit

BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.

Posted

Mean

Standard Deviation

z-score

Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

Change from baseline in heart rate in beats per minute was reported.

Posted

Mean

Standard Deviation

beats per minute

Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit

Change from baseline in PR interval, QT interval corrected using the Bazett's correction (QTcB), QT interval corrected using the Fridericia's formula (QTcF), QT interval, RR interval, QRS duration in millisecond (msec) was reported.

Posted

Mean

Standard Deviation

msec

Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total score is sum of individual item scores, ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. Rows with only non-zero data/values for change in SARS total score at specified time points, for at least 1 reporting arm, are reported below.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Global Clinical Assessment of Akathisia Subscale Score of Barnes Akathisia Rating Scale (BAS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. Global clinical assessment of akathisia subscale score of BAS, was rated on a 6-point scale range 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Movement Cluster Subscale Score of Abnormal Involuntary Movement Scale (AIMS) at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit

AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in participants, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 12 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster subscale score, giving it a possible score range of 0 (none) to 28 (maximum severity), higher scores indicate greater severity. Rows with only non-zero data/values for change in AIMS-movement cluster subscale score at specified time points, for at least 1 reporting arm, are reported below.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods [not plan], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). C-CASA categories with at least 1 participant, for specified time points, for at least 1 reporting arm are reported below.

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Count of Participants

Participants

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Week 26

CDRS-R: clinician-rated interview-based scale to assess 17 distinct symptom areas to derive an index of depression severity. Each symptom area was rated on a 7-point scale; range from 1 (no impairment) to 17 (maximum impairment). Total CDRS-R score was calculated as sum of responses for each 7 symptom areas. Total CDRS-R score ranged from 17 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment.

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Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 26

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 1, 2, 6, 14, 22, 26

YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) 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 was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 6, 14, 22, 26

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. CGI-S score ranged from 1 (not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

Secondary

Change From Baseline in Children's Global Assessment Scale (CGAS) Total Score at Week 26

CGAS: a clinician-rated global assessment item for children, based on symptoms and social functioning in home, school, and community settings. Scores ranged from 1 (extremely impaired) to 100 (doing very well), where higher levels indicate better health.

Posted

Mean

Standard Deviation

units on a scale

Baseline (last measurement from A1281198), A1281201: Week 26

ID	Title	Description
OG000	Ziprasidone in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.

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 in A1281198 and A1281201	Participants who were on ziprasidone in study A1281198, continued to receive the same dose of ziprasidone, under similar double-blind conditions for maximum up to Week 2. Participants with body weight >=45 kg had a target total daily dose range of 120-160 mg/day given in 2 divided doses with food. Participants with body weight <45 kg had a target total daily dose range of 60-80 mg/day given in 2 divided doses with food. Participants who did not tolerate a dose of 80 mg/day were allowed to have a dose reduction. The minimum permitted dose was 40 mg/day (20 mg twice a day) for all participants. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of medication.	0	10	0	10	7	10
EG001	Placebo in A1281198 Then Ziprasidone in A1281201	Participants who were on placebo in study A1281198, received ziprasidone, under similar double-blind conditions up to Week 2 (with body weight >45 kg) or Week 1 (with body weight <45 kg) and during the respective specified duration dose was titrated-up, to the appropriate weight-adjusted target dose per discretion of the investigator to maintain optimal efficacy and tolerability. Dosing of ziprasidone was identical to A1281198 study. Any participant if unable to tolerate the ziprasidone during Week 1 was discontinued from the study. Post Week 2 or Week 1 (as applicable) up to Week 26, dosing was open label and flexible. Participants had a follow-up Visit to trial site at 1 Week after last dose. Adverse events were collected up to 35 days after last dose of study medication.	0	13	1	13	12	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Aggression	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment		EG0000 affected10 at risk EG0011 affected13 at risk
Suicidal ideation	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment		EG0000 affected10 at risk EG0011 affected13 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Nausea	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0013 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Fatigue	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0017 affected13 at risk
Feeling abnormal	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Pain	General disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Helicobacter infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Influenza	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Blood insulin increased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Streptococcus test positive	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Weight decreased	Investigations	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Akathisia	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Dizziness	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0011 affected13 at risk
Dystonia	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Headache	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Lethargy	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Memory impairment	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Sedation	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Somnolence	Nervous system disorders	MedDRA v23.1	Non-systematic Assessment	EG0003 affected10 at risk EG0011 affected13 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Insomnia	Psychiatric disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA v23.1	Non-systematic Assessment	EG0001 affected10 at risk EG0010 affected13 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v23.1	Non-systematic Assessment	EG0000 affected10 at risk EG0011 affected13 at risk

Prioritization of outcome measures per study team's discretion.

Certain Agreements

ID	Term
D001714	Bipolar Disorder

ID	Term
C092292	ziprasidone

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