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High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms (HDZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403546
First Posted: November 23, 2006
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Ziprasidone 80-160 mg/d
Drug: Placebo
Drug: Ziprasidone 160 mg/d

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Upon signing informed consent participants not already taking ziprasidone were instructed to start open-label ziprasidone for 3 weeks. Of 131 participants who signed informed consent 75 started ziprasidone and 56 were already on ziprasidone. Those completing open-label and those on ziprasidone were then screened.

Reporting Groups
  Description
Standard Treatment Ziprasidone Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.
High-Dose Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
Placebo, Standard Treatment Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.

Participant Flow for 3 periods

Period 1:   Signed Informed Consent/Open-Label
    Standard Treatment Ziprasidone   High-Dose Ziprasidone   Placebo, Standard Treatment Ziprasidone
STARTED   131   0   0 
COMPLETED   103   0   0 
NOT COMPLETED   28   0   0 
Withdrew Consent                6                0                0 
Early Termination                8                0                0 
Terminated by Investigator                9                0                0 
Adverse Event                5                0                0 

Period 2:   Screening Phase
    Standard Treatment Ziprasidone   High-Dose Ziprasidone   Placebo, Standard Treatment Ziprasidone
STARTED   103   0   0 
COMPLETED   75 [1]   0   0 
NOT COMPLETED   28   0   0 
Screening Failure                22                0                0 
Adverse Event                1                0                0 
Terminated Prior to Randomization                5                0                0 
[1] All participants who completed Screening were randomized to the High-Dose and Placebo arms.

Period 3:   Randomized Trial
    Standard Treatment Ziprasidone   High-Dose Ziprasidone   Placebo, Standard Treatment Ziprasidone
STARTED   0 [1]   38   37 
COMPLETED   0   21   21 
NOT COMPLETED   0   17   16 
Early Terminations                0                17                16 
[1] All participants who completed Screening were randomized to the High-Dose and Placebo arms.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who entered the Randomized Trial.

Reporting Groups
  Description
High-Dose Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
Placebo, Standard Treatment Ziprasidone Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
Total Total of all reporting groups

Baseline Measures
   High-Dose Ziprasidone   Placebo, Standard Treatment Ziprasidone   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   37   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (12.0)   41.0  (11.9)   40.0  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  28.9%      12  32.4%      23  30.7% 
Male      27  71.1%      25  67.6%      52  69.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial   [ Time Frame: From Baseline up to Week 8 ]

2.  Primary:   Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

3.  Primary:   Change From Baseline in the Barnes Akathisia Scale (BAS)   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

4.  Primary:   Number of Participants With High and Low Levels in Serum Prolactin Concentration   [ Time Frame: Baseline, Week 8 ]

5.  Primary:   Vital Signs: Systolic and Diastolic Blood Pressure Levels   [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 ]

6.  Primary:   Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)   [ Time Frame: 6 hours after dosing of Weeks 1, 2 and 8 ]

7.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

8.  Primary:   Percentage of Participants With Response   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

9.  Primary:   Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

10.  Primary:   Number of Treatment-emergent Adverse Events During Randomized Trial   [ Time Frame: From Baseline up to Week 8 ]

11.  Secondary:   Change From Baseline in Positive Subscale Score of PANSS   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

12.  Secondary:   Change From Baseline in PANSS Negative Subscale Score   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

13.  Secondary:   Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

14.  Secondary:   Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score   [ Time Frame: Baseline, Week 8 ]

15.  Secondary:   Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score   [ Time Frame: Baseline, Week 8 ]

16.  Secondary:   Change From Baseline in Global Assessment of Functioning (GAF) Score   [ Time Frame: Baseline, Week 8 ]

17.  Secondary:   Change in Schizophrenia Cognition Rating Scale (SCoRS) Score   [ Time Frame: Baseline, Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Donald C. Goff, MD
Organization: Massachusetts General Hospital
e-mail: Donald.Goff@nyumc.org



Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00403546     History of Changes
Other Study ID Numbers: 2005-P-001372
First Submitted: November 21, 2006
First Posted: November 23, 2006
Results First Submitted: April 17, 2017
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017