Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00257192
First received: November 21, 2005
Last updated: December 2, 2011
Last verified: December 2011
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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
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. |
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
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. |
| Total | Total of all reporting groups |
Baseline Measures
| Ziprasidone | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
193 | 90 | 283 |
|
Age, Customized
[units: participants] |
|||
| >12 years and <13 years at start of treatment | 4 | 0 | 4 |
| Between 13 and 17 years | 189 | 90 | 279 |
|
Age
[units: years] Mean ± Standard Deviation |
15.3 ± 1.4 | 15.4 ± 1.4 | 15.3 ± 1.4 |
|
Gender
[units: participants] |
|||
| Female | 84 | 28 | 112 |
| Male | 109 | 62 | 171 |
|
Ethnicity
[units: participants] |
|||
| Hispanic / Latino | 21 | 9 | 30 |
| Not Hispanic / Latino | 172 | 81 | 253 |
|
Race
[units: particpants] |
|||
| White | 116 | 60 | 176 |
| Black | 17 | 2 | 19 |
| Asian | 38 | 17 | 55 |
| Hispanic | 9 | 3 | 12 |
| Other | 13 | 8 | 21 |
|
Tanner adolescent pubertal self-assessment: Breast (females)
[1] [units: particpants] |
|||
| Stage 1 | 0 | 1 | 1 |
| Stage 2 | 6 | 3 | 9 |
| Stage 3 | 16 | 4 | 20 |
| Stage 4 | 35 | 11 | 46 |
| Stage 5 | 25 | 9 | 34 |
| Not applicable | 109 | 62 | 171 |
| Missing (not answered) | 2 | 0 | 2 |
|
Tanner adolescent pubertal self-assessment: Genitalia (males)
[1] [units: participants] |
|||
| Stage 1 | 0 | 1 | 1 |
| Stage 2 | 9 | 3 | 12 |
| Stage 3 | 25 | 16 | 41 |
| Stage 4 | 57 | 26 | 83 |
| Stage 5 | 18 | 16 | 34 |
| Not applicable | 82 | 28 | 110 |
| Missing (not answered) | 2 | 0 | 2 |
|
Tanner adolescent pubertal self-assessment: Pubic hair (females and males)
[1] [units: participants] |
|||
| Stage 1 | 0 | 3 | 3 |
| Stage 2 | 13 | 7 | 20 |
| Stage 3 | 36 | 13 | 49 |
| Stage 4 | 90 | 43 | 133 |
| Stage 5 | 52 | 24 | 76 |
| Missing (not answered) | 2 | 0 | 2 |
|
Height
[units: centimeters (cm)] Mean ± Standard Deviation |
164.9 ± 10.1 | 167.8 ± 10.0 | 165.8 ± 10.1 |
|
Weight
[units: kilograms (kg)] Mean ± Standard Deviation |
61.2 ± 15.5 | 64.3 ± 15.7 | 62.2 ± 15.6 |
| [1] | At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). |
|---|
Outcome Measures
| 1. Primary: | Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6 [ Time Frame: Baseline, Week 6 ] |
| 2. Secondary: | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6 [ Time Frame: Baseline, Week 6 ] |
| 3. Secondary: | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6 [ Time Frame: Baseline, Week 6 ] |
| 4. Secondary: | Change From Baseline in PANSS: Positive and Negative Subscales at Week 6 [ Time Frame: Baseline, Week 6 ] |
| 5. Secondary: | Clinical Global Impression of Improvement (CGI-I) Score at Week 6 [ Time Frame: Baseline, Week 6 ] |
| 6. Secondary: | Change From Baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Early termination (ET) ] |
| 7. Secondary: | Change From Baseline in Child Health Questionnaire (CHQ) [ Time Frame: Baseline, Week 6, ET ] |
| 8. Secondary: | Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score [ Time Frame: Baseline, Week 1 through Week 6 ] |
| 9. Secondary: | Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score [ Time Frame: Baseline, Week 1 through Week 6 ] |
| 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 ] |
| 11. Secondary: | Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1 [ Time Frame: Baseline, Week 2, Week 6 ] |
| 12. Secondary: | Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales [ Time Frame: Baseline, Week 6, ET ] |
| 13. Secondary: | Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index [ Time Frame: Baseline, Week 6, ET ] |
| 14. Secondary: | Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS) [ Time Frame: Baseline, Week 1 through Week 6 ] |
| 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 ] |
| 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 ] |
| 17. Secondary: | Number of Subjects Per Response on the School Placement Questionnaire: School Situation [ Time Frame: Baseline, Week 2, Week 6, ET ] |
| 18. Secondary: | Number of Subjects Per Response on the School Placement Questionnaire: School Attendance [ Time Frame: Baseline, Week 2, Week 6, ET ] |
| 19. Secondary: | Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance [ Time Frame: Baseline, Week 2, Week 6, ET ] |