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

Phase 4

Completed

• Conditions: Medication Adherence; Bipolar Disorder
• Interventions: Drug: ziprasidone

• Registration Number: NCT01293825
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2013-12-28
• Results First Submitted QC: 2014-03-19
• Results First Posted: 2014-04-22
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI)
2. On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant)
3. Have weight gain concerns that individual believes are related to BD medication treatment
4. 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

1. Known resistance or intolerance to ziprasidone
2. Medical contraindication to ziprasidone
3. Individuals on ziprasidone immediately prior to study enrollment
4. Prior or current treatment with clozapine
5. Diagnosis of eating disorder
6. 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
7. 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
8. Current substance dependence
9. High risk of harm to self or others
10. Female who is currently pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medication Adherence Bipolar Disorder	ziprasidone	There was only one group in this study. All participants received the study drug Ziprasidone.

Primary Outcome Measures

Name	Time	Method
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)	Week 16	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

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

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States