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Side Effects of Newer Antipsychotics in Older Adults

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
StatusTamamlandı
Sponsorlar
Veterans Medical Research Foundation
Əməkdaşlar
National Institute of Mental Health (NIMH)

Açar sözlər

Mücərrəd

This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.

Təsvir

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.

Tarixlər

Son Doğrulandı: 11/30/2018
İlk təqdim: 10/24/2005
Təxmini qeydiyyat təqdim edildi: 10/24/2005
İlk Göndərmə: 10/26/2005
Son Yeniləmə Göndərildi: 12/12/2018
Son Yeniləmə Göndərildi: 12/16/2018
Həqiqi Təhsilin Başlama Tarixi: 07/31/2005
Təxmini İlkin Tamamlanma Tarixi: 09/30/2010
Təxmini İşin Tamamlanma Tarixi: 09/30/2010

Vəziyyət və ya xəstəlik

Schizophrenia
Alzheimer's Disease
Dementia

Müdaxilə / müalicə

Drug: 3: Aripiprazole

Drug: 4: Olanzapine

Drug: 1: Risperdal

Faza

Faza 4

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: 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.
Drug: 1: Risperdal
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
Experimental: 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.
Drug: 3: Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
Experimental: 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.
Drug: 4: Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 40 Years Üçün 40 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion Criteria:

- N/A

Nəticə

İlkin nəticə tədbirləri

1. Change in Body Mass Index [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.)

2. Change in Fasting Plasma Glucose (FPG) [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.)

3. Change in LDL cholesterol, HDL cholesterol, and triglycerides [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.)

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