Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

This study has been terminated.

(Please see Detailed Description for termination reason.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00257192

First received: November 21, 2005

Last updated: December 2, 2011

Last verified: December 2011

History of Changes

Results First Received: March 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: placebo Drug: Ziprasidone oral capsules

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.

Reporting Groups

	Description
Ziprasidone	Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo	Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Description

Ziprasidone

Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Placebo

Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Participant Flow: Overall Study

	Ziprasidone	Placebo
STARTED	193	91 ^[1]
Received Study Treatment	193	90
COMPLETED	135	52
NOT COMPLETED	58	39
Adverse Event	21	10
Laboratory abnormality	1	1
Lost to Follow-up	3	3
Insufficient clinical response	18	18
Withdrawal by Subject	14	2
Randomized but not treated	0	1
Study terminated by sponsor	1	0
Miscellaneous	0	4

[1]	Includes 1 subject randomized but not treated

Baseline Characteristics

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Outcome Measures

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1. Primary:

Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6 [ Time Frame: Baseline, Week 6 ]

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2. Secondary:

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6 [ Time Frame: Baseline, Week 6 ]

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3. Secondary:

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6 [ Time Frame: Baseline, Week 6 ]

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4. Secondary:

Change From Baseline in PANSS: Positive and Negative Subscales at Week 6 [ Time Frame: Baseline, Week 6 ]

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5. Secondary:

Clinical Global Impression of Improvement (CGI-I) Score at Week 6 [ Time Frame: Baseline, Week 6 ]

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6. Secondary:

Change From Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Early termination (ET) ]

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7. Secondary:

Change From Baseline in Child Health Questionnaire (CHQ) [ Time Frame: Baseline, Week 6, ET ]

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8. Secondary:

Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score [ Time Frame: Baseline, Week 1 through Week 6 ]

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9. Secondary:

Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score [ Time Frame: Baseline, Week 1 through Week 6 ]

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10. Secondary:

Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13 [ Time Frame: Baseline, Week 1 through Week 6 ]

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11. Secondary:

Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1 [ Time Frame: Baseline, Week 2, Week 6 ]

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12. Secondary:

Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales [ Time Frame: Baseline, Week 6, ET ]

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13. Secondary:

Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index [ Time Frame: Baseline, Week 6, ET ]

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14. Secondary:

Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) [ Time Frame: Baseline, Week 1 through Week 6 ]

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15. Secondary:

Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item [ Time Frame: Baseline, Week 1 through Week 6 ]

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16. Secondary:

Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score [ Time Frame: Baseline, Week 1 through Week 6 ]

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17. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: School Situation [ Time Frame: Baseline, Week 2, Week 6, ET ]

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18. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: School Attendance [ Time Frame: Baseline, Week 2, Week 6, ET ]

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19. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance [ Time Frame: Baseline, Week 2, Week 6, ET ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00257192 History of Changes
Other Study ID Numbers:	A1281134
Study First Received:	November 21, 2005
Results First Received:	March 23, 2010
Last Updated:	December 2, 2011
Health Authority:	United States: Food and Drug Administration

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