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

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

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 Overview

• Status: Completed
• Conditions: Bipolar Disorder; Medication Adherence
• Intervention / Treatment: Drug: ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Medication Adherence Bipolar Disorder; There was only one group in this study. All participants received the study drug Ziprasidone.

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 Names: Geodon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Pfizer
• Investigators: Principal Investigator: Martha Sajatovic, M.D., Case Western Reserve University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Body Weight; Body Weight Changes; Bipolar and Related Disorders; Bipolar Disorder; Weight Gain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: Pfizer IIR-WS883414