- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01418638
The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
Objective There is growing evidence showing a relation between depression, metabolic syndrome, diabetes, cardiovascular disease (1), serum lipid profile (2,3) and body weight (4), as well as the effects of some of the antidepressant medications on these various conditions and profiles.
The aim of the study is to examine the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder (MDD).
Group of patients:
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
Research Design and Methods:
Research duration will be 8 weeks. Patients meeting the inclusion criteria will be recruited after being diagnosed with MDD and having undertaken the HDRS. A follow-up HDRS will be taken at weeks 4 and 8. The psychiatric evaluation will be held by a resident in psychiatry.
The following metabolic parameters will be examined at base-line and at the end of the 8 weeks:
Weight, height, waist circumference, body mass index (BMI: (Weight in Kg/(Height in meters)2), sitting blood pressure (after 3 minutes of sitting).
Serum lipid profile (performed in Ziv hospital's chemistry lab): Low density lipoprotein cholesterol, High density Lipoprotein cholesterol, Triglycerides, Total cholesterol, Apolipoprotein level (Apo AI, Apo B, Apo E, Apo AII).
Fasting glucose and insulin blood levels, in order to evaluate insulin-release and resistance, according to the following formulas:
Insulin Resistance:
HOMA IR=Fasting glucose (mg/dL)x Fasting insulin (mmol/L)/405
Insulin Release:
HOMA-β={360xfasting insulin (mmol/L)}/{glucose(mg/dL)-63} Serum oxidative stress parameters according to the F2-Isoprostane kit will be measured.
Malonylaialdehyde (MDA) content in serum will be analyzed by the thiobarbituric acid reactive substances assay, which measures malondialdehyde equivalent (13). Conjugated dienes will be measured at 234nm (14, 15).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Safed, Israel, 13110
- Rekruttering
- Ziv MC
-
Ledende efterforsker:
- Osamah Hussein, MD
-
Kontakt:
- Osamah Hussein, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- MDD diagnosed patients with a Hamilton Depression Rating Scale (HDRS) score of at least 18 points. Patients not treated with medications or such that had shown resistance to treatment, and were therefore assigned for drug replacement.
- Patients on stable therapy for hypertension, diabetes mellitus, hypothyroidism, dyslipidemia and / or weight lowering medications
Exclusion Criteria:
- Patients receiving antipsychotic treatment as well as patients on mood stabilizers will be excluded.
- Patients with uncontrolled diabetes mellitus, uncontrolled thyroid functioning, or uncontrolled hypertension, as well as patients who regularly consume alcohol will be excluded.
- Patients with uncontrolled malignancy are excluded as well.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
30 Patients with MDD.
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder.
Tidsramme: 8 WEEKS
|
8 WEEKS
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Osamah Hussein, MD, Ziv Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01-11 ZIV
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 Større depressiv lidelse
-
Rotman Research Institute at BaycrestRekrutteringMajor Depressive Disorder (MDD)Canada
-
ACADIA Pharmaceuticals Inc.RekrutteringDepressiv lidelse, behandlingsresistent | Major Depressive Disorder (MDD)Forenede Stater
-
University of PretoriaIkke rekrutterer endnuMajor Depressive Disorder (MDD)Saudi Arabien
-
Tel Aviv UniversityIkke rekrutterer endnuMajor Depressive Disorder (MDD)Israel
-
Instituto Mexicano del Seguro SocialAfsluttet
-
Yonggui YuanIkke rekrutterer endnuMajor Depressive Disorder (MDD)Kina
-
Daniel LindqvistLund University; KetabonRekrutteringMajor Depressive Disorder (MDD)Sverige
-
King's College LondonCardiff and Vale University Health Board; South London and Maudsley NHS... og andre samarbejdspartnereRekrutteringMajor Depressive Disorder (MDD)Det Forenede Kongerige
-
Supernus Pharmaceuticals, Inc.RekrutteringMajor Depressive Disorder (MDD)Forenede Stater
-
University of PennsylvaniaRekruttering