Back to resultsZiprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad) (Zip Ad)
Primary Purpose
Medication Adherence, Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ziprasidone
Sponsored by
About this trial
This is an interventional treatment trial for Medication Adherence
Eligibility Criteria
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
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medication Adherence Bipolar Disorder
Arm Description
There was only one group in this study. All participants received the study drug Ziprasidone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Montgomery Asberg Depression Rating Scale
Scale Range: 0-60. Lower scores indicate better outcomes.
Young Mania Rating Scale
Scale Range: 0-60. Lower scores indicate better outcomes.
Body Weight
Quality of Life Score as Measured by 12-item Short Form Health Survey
Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
Full Information
NCT ID
NCT01293825
First Posted
February 10, 2011
Last Updated
December 8, 2014
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01293825
Brief Title
Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)
Acronym
Zip Ad
Official Title
Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medication Adherence Bipolar Disorder
Arm Type
Experimental
Arm Description
There was only one group in this study. All participants received the study drug Ziprasidone.
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
Description
Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Treatment Adherence Score as Measured by the Morisky Rating Scale
Description
Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
Time Frame
Week 16
Title
Attitude Toward Medication Score as Measured by the Drug Attitude Inventory
Description
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
Time Frame
Week 16
Title
Global Psychopathology Score as Measured by Clinical Global Impressions
Description
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.
Time Frame
Week 16
Title
Social and Occupational Functioning Scale
Description
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.
Time Frame
Week 16
Title
Montgomery Asberg Depression Rating Scale
Description
Scale Range: 0-60. Lower scores indicate better outcomes.
Time Frame
Week 16
Title
Young Mania Rating Scale
Description
Scale Range: 0-60. Lower scores indicate better outcomes.
Time Frame
Week 16
Title
Body Weight
Time Frame
Week 16
Title
Quality of Life Score as Measured by 12-item Short Form Health Survey
Description
Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, M.D.
Organizational Affiliation
Case Western Reserve University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)
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