- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00245206
Side Effects of Newer Antipsychotics in Older Adults
Metabolic Effects of Newer Antipsychotics in Older Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
California
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San Diego, California, Stati Uniti, 92037
- University of California, San Diego
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication
Exclusion Criteria:
- N/A
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Body Mass Index
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Dilip V. Jeste, MD, University of California, San Diego
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Disturbi neurocognitivi
- Spettro della schizofrenia e altri disturbi psicotici
- Malattie Neurodegenerative
- Demenza
- Tauopatie
- Schizofrenia
- Malattia di Alzheimer
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Antiemetici
- Agenti gastrointestinali
- Agenti antipsicotici
- Agenti tranquillanti
- Psicofarmaci
- Inibitori dell'assorbimento della serotonina
- Inibitori dell'assorbimento dei neurotrasmettitori
- Modulatori di trasporto a membrana
- Agenti serotoninergici
- Agenti antidepressivi
- Agonisti della dopamina
- Agenti dopaminergici
- Agonisti del recettore della serotonina 5-HT1
- Agonisti del recettore della serotonina
- Antagonisti del recettore della serotonina 5-HT2
- Antagonisti della serotonina
- Antagonisti del recettore della dopamina D2
- Antagonisti della dopamina
- Olanzapina
- Aripiprazolo
- Risperidone
Altri numeri di identificazione dello studio
- R01MH071536 (Sovvenzione/contratto NIH degli Stati Uniti)
- DATR A5-ETSE (Clinicaltrials.gov)
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .