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

8 december 2014 uppdaterad av: Martha Sajatovic, University Hospitals Cleveland Medical Center

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44106
        • University Hospitals Case Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Medication Adherence Bipolar Disorder
There was only one group in this study. All participants received the study drug Ziprasidone.
Läkemedel: 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.
Andra namn:
  • Geodon

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
Tidsram: Week 16
Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.
Week 16

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Adherence Score as Measured by the Morisky Rating Scale
Tidsram: Week 16
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
Tidsram: Week 16
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
Tidsram: 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.
Week 16
Social and Occupational Functioning Scale
Tidsram: 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.
Week 16
Montgomery Asberg Depression Rating Scale
Tidsram: Week 16
Scale Range: 0-60. Lower scores indicate better outcomes.
Week 16
Young Mania Rating Scale
Tidsram: Week 16
Scale Range: 0-60. Lower scores indicate better outcomes.
Week 16
Body Weight
Tidsram: Week 16
Week 16
Quality of Life Score as Measured by 12-item Short Form Health Survey
Tidsram: Week 16
Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
Week 16

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospitals Cleveland Medical Center

Samarbetspartners

Pfizer

Utredare

  • Huvudutredare: Martha Sajatovic, M.D., Case Western Reserve University School of Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2011

Primärt slutförande (Faktisk)

1 augusti 2012

Avslutad studie (Faktisk)

1 augusti 2012

Studieregistreringsdatum

Först inskickad

10 februari 2011

Först inskickad som uppfyllde QC-kriterierna

10 februari 2011

Första postat (Uppskatta)

11 februari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 december 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 december 2014

Senast verifierad

1 december 2014

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pfizer IIR-WS883414

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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