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

• ClinicalTrials.gov Identifier: NCT01293825
• Recruitment Status: Completed
• First Posted: February 11, 2011
• Results First Posted: April 22, 2014
• Last Update Posted: December 30, 2014
• Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Pfizer
• Information provided by (Responsible Party): Martha Sajatovic, University Hospitals Cleveland Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Medication Adherence; Bipolar Disorder	Drug: ziprasidone	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder
• Study Start Date: January 2011
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

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 Name: Geodon

Outcome Measures

Primary Outcome Measures :

1. Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) [ Time Frame: 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 :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Ohio

University Hospitals Case Medical Center

Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals Cleveland Medical Center

Pfizer

Investigators

• Principal Investigator: Martha Sajatovic, M.D.; Case Western Reserve University School of Medicine

More Information

• Responsible Party: Martha Sajatovic, Professor of Psychiatry, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT01293825
• Other Study ID Numbers: Pfizer IIR-WS883414
• First Posted: February 11, 2011
• Results First Posted: April 22, 2014
• Last Update Posted: December 30, 2014
• Last Verified: December 2014

Additional relevant MeSH terms:

Weight Gain; Bipolar Disorder; Bipolar and Related Disorders; Mental Disorders; Body Weight Changes; Body Weight; Ziprasidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents