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

Study Overview
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Brief Summary
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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.

Official Title
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Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder

Conditions
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Medication Adherence, Bipolar Disorder

Intervention / Treatment
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* Drug: ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI) On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant) Have weight gain concerns that individual believes are related to BD medication treatment Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the offending agent in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies Exclusion Criteria: Known resistance or intolerance to ziprasidone Medical contraindication to ziprasidone Individuals on ziprasidone immediately prior to study enrollment Prior or current treatment with clozapine Diagnosis of eating disorder Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial Current substance dependence High risk of harm to self or others Female who is currently pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Adherence Bipolar Disorder<br>There was only one group in this study. All participants received the study drug Ziprasidone. | Drug: ziprasidone<br>* 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.<br>* Other names: Geodon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) | Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Adherence Score as Measured by the Morisky Rating Scale | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes. | Week 16 | 
| Attitude Toward Medication Score as Measured by the Drug Attitude Inventory | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. | Week 16 | 
| Global Psychopathology Score as Measured by Clinical Global Impressions | 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. | Week 16 | 
| Social and Occupational Functioning Scale | 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. | Week 16 | 
| Montgomery Asberg Depression Rating Scale | Scale Range: 0-60. Lower scores indicate better outcomes. | Week 16 | 
| Young Mania Rating Scale | Scale Range: 0-60. Lower scores indicate better outcomes. | Week 16 | 
| Body Weight |  | Week 16 | 
| Quality of Life Score as Measured by 12-item Short Form Health Survey | Scale Range: 1-99th percentile score. Higher scores indicate better outcomes. | Week 16 |