- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00421369
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The lifetime risk for major depressive disorder (MDD) is 15% in the general population. Current treatment approaches emphasize the achievement of remission. Remission implies virtual absence of depressive symptoms and is associated with better function and a better overall prognosis than response, which is usually defined as a 50% reduction in symptom severity. Sixty percent or more of patients treated optimally with antidepressants remain un-remitted and will need additional treatment. A potentially effective but under-exploited strategy to augment antidepressant effects is concurrent administration of the thyroid hormone, triiodothyronine (T3). We previously demonstrated the clinical efficacy and safety of T3 administered concurrently with the SSRI, sertraline, in the context of a randomized, double-blind placebo-controlled trial. Although all the patients were euthyroid, remission rates were significantly higher in the sertraline plus T3 group and were associated with significantly lower baseline T3 values and a significant decrease in serum thyroid stimulating hormone (TSH) values during the course of treatment.
The study aims to:
- Delineate a sub-population of depressed patients treated with sertraline, who are more likely to respond to T3 augmentation on the basis of thyroid function and genetic variation in thyroid pathway genes.
- Investigate the appropriate timing for the addition of T3.
- Assess the efficacy of reboxetine, a specific noradrenaline reuptake inhibitor, as a further supplement to the treatment of un-remitted patients. The results of this study could have a significant, direct clinical impact on the pharmacological treatment of MDD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jerusalem, Israel
- Hadassah Medical Organization
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (21 items, HAM-D) total >16 with item 1 (depressed mood) >2.
- Age 18-70 years.
- Male or female.
- Competent and willing to give written informed consent.
Exclusion Criteria:
- Clinical hyper- or hypothyroidism or any other thyroid illness.
- Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
- Significant suicidal risk [HAM-D item 3 (suicide) >2].
- Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
- Treatment with the antidepressant, sertraline, in current episode.
- More then one antidepressant trial or any augmentation treatment during current episode.
- Length of current episode >12 months
- Female subjects pregnant or lactating or not using adequate contraception.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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treatment outcome defined categorically as Remission: A Hamilton Depression Scale (HAM-D) less or equal to 6.
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Secondary Outcome Measures
Outcome Measure |
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RESPONSE: Based on Hamilton Depression Scale (HAM-D)reduction of >50% from baseline to endpoint..
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REMISSION: Based on the other rating scales applied in this project.
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RESPONSE: Based on the other rating scales applied in this project.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Adrenergic Uptake Inhibitors
- Sertraline
- Reboxetine
Other Study ID Numbers
- t3rbx-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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