Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01293825
First received: February 10, 2011
Last updated: March 19, 2014
Last verified: March 2014
Results First Received: December 28, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Medication Adherence
Bipolar Disorder
Intervention: Drug: ziprasidone

  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
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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
Medication Adherence Bipolar Disorder

Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.

There was only one group for this study.


Participant Flow:   Overall Study
    Medication Adherence Bipolar Disorder  
STARTED     30  
COMPLETED     20  
NOT COMPLETED     10  



  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.
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Reporting Groups
  Description
Medication Adherence Bipolar Disorder

Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.

There was only one group for this study.


Baseline Measures
    Medication Adherence Bipolar Disorder  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  44.2  ± 10.2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     1  
Gender  
[units: participants]
 
Female     15  
Male     15  



  Outcome Measures
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1.  Primary:   Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)   [ Time Frame: Week 16 ]

2.  Secondary:   Treatment Adherence Score as Measured by the Morisky Rating Scale   [ Time Frame: Week 16 ]

3.  Secondary:   Attitude Toward Medication Score as Measured by the Drug Attitude Inventory   [ Time Frame: Week 16 ]

4.  Secondary:   Global Psychopathology Score as Measured by Clinical Global Impressions   [ Time Frame: Week 16 ]

5.  Secondary:   Social and Occupational Functioning Scale   [ Time Frame: Week 16 ]

6.  Secondary:   Montgomery Asberg Depression Rating Scale   [ Time Frame: Week 16 ]

7.  Secondary:   Young Mania Rating Scale   [ Time Frame: Week 16 ]

8.  Secondary:   Body Weight   [ Time Frame: Week 16 ]

9.  Secondary:   Quality of Life Score as Measured by 12-item Short Form Health Survey   [ Time Frame: Week 16 ]


  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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Martha Sajatovic, Professor of Psychiatry
Organization: University Hospitals of Cleveland
phone: (216) 844-2808
e-mail: martha.sajatovic@uhhospitals.org


No publications provided


Responsible Party: Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01293825     History of Changes
Other Study ID Numbers: Pfizer IIR-WS883414
Study First Received: February 10, 2011
Results First Received: December 28, 2013
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board