- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00245206
Side Effects of Newer Antipsychotics in Older Adults
Metabolic Effects of Newer Antipsychotics in Older Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.
Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
California
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San Diego, California, Forente stater, 92037
- University of California, San Diego
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication
Exclusion Criteria:
- N/A
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1: Risperdal
Participants randomized to this arm will be prescribed risperdal.
They will continue to be followed by their psychiatrist.
In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
|
Participant will take risperidone.
Dosing will be determined by each participant's psychiatrist.
Andre navn:
|
Eksperimentell: 3: Aripiprazole
Participants randomized to this arm will be prescribed aripiprazole.
They will continue to be followed by their psychiatrist.
In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
|
Participant will take aripiprazole.
Dosing will be determined by each participant's psychiatrist.
|
Eksperimentell: 4: Olanzapine
Participants randomized to this arm will be prescribed olanzapine.
They will continue to be followed by their psychiatrist.
In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
|
Participant will take olanzapine.
Dosing will be determined by each participant's psychiatrist.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Body Mass Index
Tidsramme: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Change in body mass index (BMI) between each study visit.
weight and height will be combined to report BMI in kg/m^2.
(This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
|
Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Change in Fasting Plasma Glucose (FPG)
Tidsramme: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits.
(This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
|
Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Change in LDL cholesterol, HDL cholesterol, and triglycerides
Tidsramme: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits.
(This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
|
Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dilip V. Jeste, MD, University of California, San Diego
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Jin H, Shih PA, Golshan S, Mudaliar S, Henry R, Glorioso DK, Arndt S, Kraemer HC, Jeste DV. Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization. J Clin Psychiatry. 2013 Jan;74(1):10-8. doi: 10.4088/JCP.12m08001. Epub 2012 Nov 27.
- Jin H, Meyer J, Mudaliar S, Henry R, Khandrika S, Glorioso DK, Kraemer H, Jeste D. Use of clinical markers to identify metabolic syndrome in antipsychotic-treated patients. J Clin Psychiatry. 2010 Oct;71(10):1273-8. doi: 10.4088/JCP.09m05414yel.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Nevrokognitive lidelser
- Schizofrenispektrum og andre psykotiske lidelser
- Nevrodegenerative sykdommer
- Demens
- Tauopatier
- Schizofreni
- Alzheimers sykdom
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Antiemetika
- Gastrointestinale midler
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninopptakshemmere
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Serotoninmidler
- Antidepressive midler
- Dopaminagonister
- Dopaminmidler
- Serotonin 5-HT1-reseptoragonister
- Serotoninreseptoragonister
- Serotonin 5-HT2-reseptorantagonister
- Serotonin-antagonister
- Dopamin D2-reseptorantagonister
- Dopaminantagonister
- Olanzapin
- Aripiprazol
- Risperidon
Andre studie-ID-numre
- R01MH071536 (U.S. NIH-stipend/kontrakt)
- DATR A5-ETSE (Clinicaltrials.gov)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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. .
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