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An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients

14. december 2015 opdateret af: Dr. Roumen Milev, Queen's University

OBJECTIVES:

Primary Objective:

To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression.

Secondary Objectives:

To assess the subjective changes in sleep quality parameters before and at different stages after introduction of olanzapine in treatment, longitudinally, and to correlate these changes with measures of illness severity and changes in cognition.

STUDY DESIGN:

Prospective, double blind, randomized polysomnographic (PSG) study of patients before and after treatment with olanzapine.

PSG recordings will be done three times throughout the study: before starting olanzapine augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep quality scales, and cognition measurements will be completed at each visit.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 4X3
        • Queen's University, Providence Care-Mental Health Services

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:

  1. A diagnosis of major depressive disorder or bipolar disorder type 1, 2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
  2. Current depressive episode with a HAMD-17 of > 15
  3. Males or females over age18 years (yrs)
  4. Inpatients or outpatients
  5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
  6. Able to understand and comply with the requirements of the study
  7. Provision of written informed consent

Exclusion Criteria:

  1. Current manic, hypomanic or mixed episode, with YMRS > 12
  2. Current or past diagnosis of schizophrenia and dementia
  3. Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing
  4. Patient on any other antipsychotic medication
  5. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  6. Known intolerance or lack of response to olanzapine, as judged by the investigator
  7. Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study
  8. No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading
  9. Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization
  10. Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  11. Serious, unstable or inadequately treated medical illness as judged by the investigator
  12. History of epilepsy or uncontrolled seizures
  13. Involvement in the planning and conduct of the study
  14. Previous enrolment in the present study
  15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: Olanzapine
Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
Placebo komparator: 2
Medicin: Placebo
An inactive form of the treatment will be taken once daily at 6pm for 1 month.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.
Tidsramme: 3 days after baseline and 1 month after baseline
3 days after baseline and 1 month after baseline

Sekundære resultatmål

Resultatmål
Tidsramme
Sleep measures: time in bed, total sleep time, sleep period time, percentage of sleep stages (stage 1, stage 2, slow wave sleep, REM sleep) of sleep period time, sleep latency to stage 1 and 2, REM latency, number of awakenings.
Tidsramme: measure taken at baseline, 3 days after baseline, and 1 month after baseline
measure taken at baseline, 3 days after baseline, and 1 month after baseline
Respiratory events (during PSG): obstructive sleep apneas, mixed apneas, central apneas, total apneas, obstructive hypopneas, mixed hypopneas, central hypopneas, total hypopneas, and apneas + hypopneas (AHI), oxygen saturation, and heart rate.
Tidsramme: Baseline, 3 days and 1 month after baseline
Baseline, 3 days and 1 month after baseline
Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.
Tidsramme: Baseline, 3 days and 1 month after baseline
Baseline, 3 days and 1 month after baseline
Changes in weight and blood glucose will be monitored.
Tidsramme: At baseline and 1 month
At baseline and 1 month
Cognition: CANTAB scores
Tidsramme: Baseline, 3 days and 1 month after baseline
Baseline, 3 days and 1 month after baseline
Illness severity: HDRS-17, MADRS, CGI and HamA
Tidsramme: Baseline, 3 days and 1 month after baseline
Baseline, 3 days and 1 month after baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Queen's University

Samarbejdspartnere

Eli Lilly and Company

Efterforskere

  • Ledende efterforsker: Roumen Milev, M.D., Queen's University, Department of Psychiatry

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.

Generelle publikationer

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. oktober 2007

Primær færdiggørelse (Faktiske)

1. maj 2009

Studieafslutning (Faktiske)

1. maj 2009

Datoer for studieregistrering

Først indsendt

22. august 2007

Først indsendt, der opfyldte QC-kriterier

22. august 2007

Først opslået (Skøn)

24. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PSIY-263-07

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 Depressiv lidelse

Kliniske forsøg med Olanzapine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner