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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. desember 2014 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Case Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Medication Adherence Bipolar Disorder
There was only one group in this study. All participants received the study drug Ziprasidone.
Legemiddel: 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.
Andre navn:
  • Geodon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment Adherence Score as Measured by the Morisky Rating Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
Scale Range: 0-60. Lower scores indicate better outcomes.
Week 16
Young Mania Rating Scale
Tidsramme: Week 16
Scale Range: 0-60. Lower scores indicate better outcomes.
Week 16
Body Weight
Tidsramme: Week 16
Week 16
Quality of Life Score as Measured by 12-item Short Form Health Survey
Tidsramme: Week 16
Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
Week 16

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospitals Cleveland Medical Center

Samarbeidspartnere

Pfizer

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2011

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

10. februar 2011

Først innsendt som oppfylte QC-kriteriene

10. februar 2011

Først lagt ut (Anslag)

11. februar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. desember 2014

Sist bekreftet

1. desember 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pfizer IIR-WS883414

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på ziprasidone

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

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