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Risks for Insulin Resistance and Metabolic Syndrome Between Major Depressive Disorder (MDD) or MDD With Psychotic Features

10 lutego 2017 zaktualizowane przez: John D. Matthews, Massachusetts General Hospital

Comparative Risks for Insulin Resistance and Metabolic Syndrome (MS) Among Hospitalized Patients With Major Depressive Disorder With (MDpsy) or Without (MDD) Psychotic Features

Studies have shown that people with certain disorders have an increased risk of developing a condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more about MS among people staying in the hospital for treatment of Major Depressive Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators also want to learn more about a stress hormone called cortisol that is made in the body. Those who take part in this study will answer some questionnaires, be given some psychiatric interviews, and have some blood taken along with a urine sample.

The investigators believe that patients in the hospital with MDpsy will have higher baseline rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance, compared with MDD alone.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

Metabolic syndrome (MS) is a combination of medical problems that can increase the risk of heart disease and diabetes in some people. People with MS can have some or all of the following:

  • High blood glucose
  • High blood pressure
  • Abdominal obesity
  • Low levels of high-density lipoprotein (HDL) cholesterol
  • High levels of triglycerides

Some studies have shown that people with certain disorders have a greater risk for developing MS. This may be because of a combination of factors, including but not limited to the type of medications used, age, and whether or not someone smokes. This study will also aim to learn more about a naturally-occurring stress hormone called cortisol that is made in the body.

In order to measure these factors, the following things will occur:

  • administer a number of questionnaires
  • gather information from medical history
  • gather information about current psychiatric mood
  • draw blood and collect a urine sample

To study the amount of cortisol in the body, a dexamethasone suppression test (DST) will be given. This test involves taking a single 1mg pill of dexamethasone, a steroid, and numerous blood draws. Like any drug, it has some risks, however it is unlikely any side effects will occur because of the low dose administered.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

14

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 85 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Eligible subjects are people who are inpatient in the medical-psychiatric unit at Massachusetts General Hospital. Included subjects have working diagnosis of major depressive disorder (MDD) or major depressive disorder with psychotic features (MDpsy).

Opis

Inclusion Criteria:

  • Capable of giving informed consent
  • DSM-IV TR diagnosis of Major Depressive Disorder with (MDpsy) or without (MDD) Psychotic Features
  • Age between 18 and 85, inclusive
  • Pre-existing Hyperlipidemia, Hypertension, and Diabetes must be stable with laboratory and clinical results within acceptable range; with or without medication for three months prior to admission

Exclusion Criteria:

  • DSM-IV TR diagnosis of: schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, organic mental disorder, substance use dependence including alcohol, that has been active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified
  • Subjects that meet criteria for substance or alcohol dependence more recently than three months prior to entering the study
  • Subjects that meet criteria for substance or alcohol abuse more recently than four weeks prior to entering the study
  • Pregnancy
  • Unstable or inadequately treated pre-existing hyperlipidemia, hypertension, and diabetes
  • Subjects who are involuntarily committed.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Ciężkie zaburzenie depresyjne
Major Depressive Disorder with Psychotic Features

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.
Ramy czasowe: Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
To preserve statistical power, we will measure insulin as a continuous variable rather than dichotomizing participants into insulin sensitive vs insulin resistant.
Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
The first secondary measure is a fasting lipid panel, including fasting total cholesterol, fasting LDL, fasting HDL, and fasting triglycerides; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Fasting glucose will be a separate secondary outcome measure; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Waist Circumference; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Waist circumference will be measured once at admission and once at discharge to determine if any changes have occurred throughout time of inpatient hospitalization
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Urine microalbumin; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
C-reactive Protein; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Homocysteine; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Blood pressure (supine & standing as available)
Ramy czasowe: We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
Cortisol; we want to measure a change in data from admission to discharge
Ramy czasowe: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Cortisol levels will be measured before and after a dexamethasone suppression test is administered at admission and discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Massachusetts General Hospital

Współpracownicy

National Alliance for Research on Schizophrenia and Depression

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2011

Zakończenie podstawowe (Rzeczywisty)

1 września 2012

Ukończenie studiów (Rzeczywisty)

1 września 2012

Daty rejestracji na studia

Pierwszy przesłany

15 lutego 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 marca 2011

Pierwszy wysłany (Oszacować)

8 marca 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lutego 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 lutego 2017

Ostatnia weryfikacja

1 lutego 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2009-P-002723

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