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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT01418638 |
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Date of registration:
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16/08/2011 |
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Primary sponsor: |
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Public title:
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The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder
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Scientific title:
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The Metabolic Effects of Antidepressants in Patients Diagnosed With Major Depressive Disorder |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01418638 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Israel
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Contacts
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Name:
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Osamah Hussein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Osamah Hussein, MD |
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Address:
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Telephone:
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Email:
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osama.h@ziv.health.gov.il |
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Affiliation:
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Name:
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Osamah Hussein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ziv Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Primary Outcome(s)
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the influence of antidepressant medications on the metabolic profiles (5) of patients suffering from Major Depressive Disorder.
[Time Frame: 8 WEEKS]
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Secondary ID(s)
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01-11 ZIV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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