The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Osamah Hussein, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01418638
First received: August 16, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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).


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder. [ Time Frame: 8 WEEKS ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
30 Patients with MDD.
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418638

Contacts
Contact: Osamah Hussein, MD osama.h@ziv.health.gov.il

Locations
Israel
Ziv MC Recruiting
Safed, Israel, 13110
Contact: Osamah Hussein, MD         
Principal Investigator: Osamah Hussein, MD         
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Osamah Hussein, MD Ziv Medical Center
  More Information

No publications provided

Responsible Party: Osamah Hussein, Osamah Hussein, MD, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01418638     History of Changes
Other Study ID Numbers: 01-11 ZIV
Study First Received: August 16, 2011
Last Updated: February 19, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
Major Depressive Disorder
Antidepressants

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014