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

This study is ongoing, but not recruiting participants.
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: May 1, 2012
Last verified: May 2012
  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%


Secondary Outcome Measures:
  • Treatment adherence score as measured by the Morisky Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-4

  • Attitude toward medication score as measured by the Drug Attitude Inventory [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-10

  • Global psychopathology score as measured by Clinical Global Impressions [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 1-7

  • Social and Occupational Functioning Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-100

  • Montgomery Asberg Depression Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60

  • Young Mania Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60

  • body weight [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Laboratory testing [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    baseline electrolytes, renal function, thyroid function, liver function tests, lipid profile and CBC with differential, B12/folate

  • 12-lead EKG [ Time Frame: Week 12 ] [ 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

  • Blood Pressure [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Height [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
Last Updated: May 1, 2012
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 April 16, 2014