A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00634348
Collaborator
(none)
256
41
2
11
6.2
0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care
Study Start Date :
Apr 1, 2004
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Aripiprazole

Drug: Aripiprazole
Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days

Active Comparator: Ziprasidone

Drug: Ziprasidone
Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. [28 days]

  2. Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores. [28 days]

Secondary Outcome Measures

  1. Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores. [28 days]

  2. Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores. [28 days]

  3. Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores. [28 days]

  4. Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. [28 days]

  5. Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. [28 days]

  6. Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. [28 days]

  7. Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. [28 days]

  8. Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. [28 days]

  9. Change from baseline to endpoint in Patient Preference Scale (PPS) scores. [28 days]

  10. Change from baseline to endpoint in Life Skills Profile (LSP). [28 days]

  11. Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. [28 days]

  12. Change from baseline to endpoint in Cognitive Battery. [28 days]

  13. Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. [28 days]

  14. Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores. [28 days]

  15. Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. [28 days]

  16. Change from baseline to Day 28 in movement disorder rating scale scores. [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Hospitalized patients with schizophrenia or schizoaffective disorder

  • At least a 6th grade reading level

  • Males or females, between 18 and 70 years of age at the time of consent

  • Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening

Exclusion Criteria:
  • Psychiatric disorder other than schizophrenia or schizoaffective disorder

  • History of arrhythmia, heart attack, or heart failure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Anaheim California United States 92804
2 Pfizer Investigational Site Cerritos California United States 90703
3 Pfizer Investigational Site Culver City California United States 90232
4 Pfizer Investigational Site Garden Grove California United States 92845
5 Pfizer Investigational Site Glendale California United States 91206
6 Pfizer Investigational Site La Mesa California United States 91942
7 Pfizer Investigational Site Newport Beach California United States 92663
8 Pfizer Investigational Site Paramount California United States 90723
9 Pfizer Investigational Site Riverside California United States 92506
10 Pfizer Investigational Site San Diego California United States 92105
11 Pfizer Investigational Site San Diego California United States 92123
12 Pfizer Investigational Site San Diego California United States 92126
13 Pfizer Investigational Site Torrance California United States 90505
14 Pfizer Investigational Site Upland California United States 91786
15 Pfizer Investigational Site Washington District of Columbia United States 20016
16 Pfizer Investigational Site Hialeah Florida United States 33016
17 Pfizer Investigational Site Shreveport Louisiana United States 71101
18 Pfizer Investigational Site Baltimore Maryland United States 21202
19 Pfizer Investigational Site Rockville Maryland United States 20850
20 Pfizer Investigational Site Saint Louis Missouri United States 63104
21 Pfizer Investigational Site Saint Louis Missouri United States 63118
22 Pfizer Investigational Site Clementon New Jersey United States 08021
23 Pfizer Investigational Site Princeton New Jersey United States 08540
24 Pfizer Investigational Site Westampton New Jersey United States 08060
25 Pfizer Investigational Site Willingboro New Jersey United States 08046
26 Pfizer Investigational Site Jamaica New York United States 11418
27 Pfizer Investigational Site Staten Island New York United States 10305
28 Pfizer Investigational Site Butner North Carolina United States 27509
29 Pfizer Investigational Site Chapel Hill North Carolina United States 27599-7160
30 Pfizer Investigational Site Durham North Carolina United States 27705
31 Pfizer Investigational Site Raleigh North Carolina United States 27603
32 Pfizer Investigational Site Cincinnati Ohio United States 45220
33 Pfizer Investigational Site Cincinnati Ohio United States 45267-0559
34 Pfizer Investigational Site Oklahoma City Oklahoma United States 73118
35 Pfizer Investigational Site Bellaire Texas United States 77401
36 Pfizer Investigational Site Dallas Texas United States 75228
37 Pfizer Investigational Site Houston Texas United States 77008
38 Pfizer Investigational Site Irving Texas United States 75062
39 Pfizer Investigational Site Arlington Virginia United States 22204
40 Pfizer Investigational Site Arlington Virginia United States 22205
41 Pfizer Investigational Site Falls Church Virginia United States 22041

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00634348
Other Study ID Numbers:
  • A1281110
First Posted:
Mar 13, 2008
Last Update Posted:
Feb 21, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2021