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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01293825
First received: February 10, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Medication Adherence
Bipolar Disorder
Drug: ziprasidone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60. Lower scores indicate better outcomes.

  • Young Mania Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60. Lower scores indicate better outcomes.

  • Body Weight [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Quality of Life Score as Measured by 12-item Short Form Health Survey [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293825

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Pfizer
Investigators
Principal Investigator: Martha Sajatovic, M.D. Case Western Reserve University School of Medicine
  More Information

No publications provided

Responsible Party: Martha Sajatovic, Professor of Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01293825     History of Changes
Other Study ID Numbers: Pfizer IIR-WS883414
Study First Received: February 10, 2011
Results First Received: December 28, 2013
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Weight Gain
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Ziprasidone
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014