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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 25 February 2013
Main ID:  NCT01418638
Date of registration: 16/08/2011
Primary sponsor: Ziv Hospital
Public title: The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
Scientific title: The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
Date of first enrolment: May 2012
Target sample size: 30
Recruitment status: Recruiting
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
Key inclusion & exclusion 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

- Patients with uncontrolled malignancy are excluded as well.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Major Depressive Disorder
Primary Outcome(s)
the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder. [Time Frame: 8 WEEKS]
Secondary Outcome(s)
Secondary ID(s)
01-11 ZIV
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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