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

NCT01293825 | Completed Phase 4 Results DMC

• 1 other identifier: Pfizer IIR-WS883414
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Treatment Adherence Score as Measured by the Morisky Rating Scale

  Week 16

• Attitude Toward Medication Score as Measured by the Drug Attitude Inventory

  Week 16

• Global Psychopathology Score as Measured by Clinical Global Impressions

  Week 16

• Social and Occupational Functioning Scale

  Week 16

• Montgomery Asberg Depression Rating Scale

  Week 16

Study Arms (1)

Medication Adherence Bipolar Disorder

EXPERIMENTAL

There was only one group in this study. All participants received the study drug Ziprasidone.

Drug: ziprasidone

Interventions

ziprasidone DRUG

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.

Also known as: Geodon

Medication Adherence Bipolar Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known resistance or intolerance to ziprasidone
• Medical contraindication to ziprasidone
• Individuals on ziprasidone immediately prior to study enrollment
• Prior or current treatment with clozapine
• Diagnosis of eating disorder
• 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
• 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
• Current substance dependence
• High risk of harm to self or others
• Female who is currently pregnant or breastfeeding

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Medication Adherence; Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Martha Sajatovic, Professor of Psychiatry
• Organization: University Hospitals of Cleveland

martha.sajatovic@uhhospitals.org

(216) 844-2808

Study Officials

• Martha Sajatovic, M.D.

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 30, 2014
• Results First Posted: April 22, 2014

Record last verified: 2014-12

Locations

US (1)