Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)
Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder|
- Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.
- Treatment Adherence Score as Measured by the Morisky Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
- Attitude Toward Medication Score as Measured by the Drug Attitude Inventory [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
- Global Psychopathology Score as Measured by Clinical Global Impressions [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes.
- Social and Occupational Functioning Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.
- Montgomery Asberg Depression Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Scale Range: 0-60. Lower scores indicate better outcomes.
- Young Mania Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Scale Range: 0-60. Lower scores indicate better outcomes.
- Body Weight [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
- Quality of Life Score as Measured by 12-item Short Form Health Survey [ Time Frame: Week 16 ] [ Designated as safety issue: No ]Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
|Study Start Date:||January 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Medication Adherence Bipolar Disorder
There was only one group in this study. All participants received the study drug Ziprasidone.
Patients will identify which psychotropic they currently receive that causes the most weight-gain concern. For individuals on multiple drugs, one drug must be identified as the "offending agent". Study psychiatrist will switch the "offending agent" to ziprasidone. Participants will be switched to ziprasidone per package insert. Patients will be maintained on ziprasidone for 12 weeks (active part of study). After the active part of the study they will return to the care of their normal clinical provider who will determine whether they will continue on ziprasidone.
Other Name: Geodon
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293825
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Martha Sajatovic, M.D.||Case Western Reserve University School of Medicine|