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Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

9. maj 2013 opdateret af: The Medical Research Network

An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression

The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:

  • antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
  • Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
  • even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
  • antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
  • non-response and loss of response are common reactions to antidepressants in Bipolar II patients

This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.

This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.

Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10024
        • Medical Research Network, L.L.C.
    • Texas
      • Plano, Texas, Forenede Stater, 75024
        • The Mech Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
  • patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
  • minimum score of 18 on the 17-item HAM-D at screen and baseline

Exclusion Criteria:

  • patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
  • patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
  • Suicidal ideation or history that makes participation in a clinical trial unduly risky
  • unstable medical conditions or any abnormality in thyroid function
  • patients with a QTc of 450msec or greater on the initial ECG
  • patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
  • the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
  • patients with dementia or substance abuse in the last 6 months
  • pregnant or lactating women will be excluded, as will those not using adequate forms of contraception

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ziprasidone
Ziprasidone monotherapy, 20-60 mg BID.
Medicin: Ziprasidone
Ziprasidone 20-60 mg BID, taken orally.
Andre navne:
  • Geodon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
Tidsramme: Week 8
Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
Tidsramme: Week 8
Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.
Week 8
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
Tidsramme: Week 8
Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.
Week 8
Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2
Tidsramme: Week 8

Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.

18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial.
Week 8
Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
Tidsramme: Week 8
Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.
Week 8
Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Tidsramme: Week 8
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.
Week 8
Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
Tidsramme: Week 8
Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.
Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Medical Research Network

Samarbejdspartnere

Pfizer
Liebowitz, Michael R., M.D.

Efterforskere

  • Ledende efterforsker: Michael R Liebowitz, MD, Medical Research Network, L.L.C.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2005

Primær færdiggørelse (Faktiske)

1. februar 2008

Studieafslutning (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

7. oktober 2005

Først indsendt, der opfyldte QC-kriterier

7. oktober 2005

Først opslået (Skøn)

12. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2013

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 04-3945-A 01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Major Depressive Episode

Kliniske forsøg med Ziprasidone

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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