Safety And Tolerability 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:

NCT00265382

First received: December 12, 2005

Last updated: December 2, 2011

Last verified: December 2011

History of Changes

Results First Received: April 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Schizophrenia
Intervention:	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
This study enrolled adolescent subjects with schizophrenia, ages 13-17 years, who participated in the double-blind placebo controlled Study A1281134 (NCT00257192) who met qualification criteria and wished to receive treatment with open-label ziprasidone.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ziprasidone	Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).

Description

Ziprasidone

Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).

Participant Flow: Overall Study

	Ziprasidone
STARTED	221
COMPLETED	76
NOT COMPLETED	145
Adverse Event	21
Laboratory Abnormality	1
Lost to Follow-up	3
Lack of Efficacy	6
Miscellaneous	6
Withdrawal by Subject	13
Study terminated by sponsor	94
Death	1

Baseline Characteristics

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Reporting Groups

	Description
Ziprasidone	Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).

Baseline Measures

	Ziprasidone
Number of Participants [units: participants]	221
Age, Customized ^[1] [units: Participants]
>12 years and <13 years at start of treatment	3
13 to 17 years	218
Gender [units: Participants]
Female	90
Male	131

[1]	Baseline data are from the preceding Study A1281134 (NCT00257192).

Outcome Measures

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1. Primary:

Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 26 weeks ]

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2. Secondary:

Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment [ Time Frame: Baseline, Week 26, Early Termination (ET) ]

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3. Secondary:

Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score [ Time Frame: Baseline, Weeks 2, 6, 18, 26, ET ]

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4. Secondary:

Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

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5. Secondary:

Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales [ Time Frame: Baseline, Weeks 6 and 26, ET ]

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6. Secondary:

Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index [ Time Frame: Baseline, Weeks 6 and 26, ET ]

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7. Secondary:

Change From Baseline in Simpson-Angus Rating Scale (SARS) [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

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8. Secondary:

Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

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9. Secondary:

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

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10. Secondary:

Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score [ Time Frame: Baseline, Weeks 2, 6, 18, 26, ET ]

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11. Secondary:

Change From Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, Weeks 2, 6, 18, 26, ET ]

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12. Secondary:

Change From Baseline in Child Health Questionnaire (CHQ) [ Time Frame: Baseline, Weeks 6 and 26, ET ]

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13. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: School Situation [ Time Frame: Baseline, Weeks 6 and 26, ET ]

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14. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: School Attendance [ Time Frame: Baseline, Weeks 6 and 26, ET ]

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15. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance [ Time Frame: Baseline, Weeks 6 and 26, 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:	NCT00265382 History of Changes
Other Study ID Numbers:	A1281135
Study First Received:	December 12, 2005
Results First Received:	April 16, 2010
Last Updated:	December 2, 2011
Health Authority:	United States: Food and Drug Administration

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