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

This study is currently recruiting participants.
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

August 16, 2011
February 19, 2013
May 2012
October 2013   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT01418638 on ClinicalTrials.gov Archive Site
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The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

Major Depressive Disorder
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30 Patients with MDD.
30 Patients aged 18-65, who were diagnosed with MDD according to the DSM-IV criteria.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Osamah Hussein, MD osama.h@ziv.health.gov.il
Israel
 
NCT01418638
01-11 ZIV
No
Osamah Hussein, Ziv Hospital
Ziv Hospital
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Principal Investigator: Osamah Hussein, MD Ziv Medical Center
Ziv Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP