Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00421369
First received: January 11, 2007
Last updated: March 21, 2013
Last verified: January 2007
  Purpose

In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to respond to T3 and establish the time in the treatment course when T3 should be added. The results of this project could have significant, direct clinical implications.


Condition Intervention
Major Depressive Disorder
Drug: sertraline
Drug: triiodothyronine (T3)
Drug: reboxetine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • treatment outcome defined categorically as Remission: A Hamilton Depression Scale (HAM-D) less or equal to 6.

Secondary Outcome Measures:
  • RESPONSE: Based on Hamilton Depression Scale (HAM-D)reduction of >50% from baseline to endpoint..
  • REMISSION: Based on the other rating scales applied in this project.
  • RESPONSE: Based on the other rating scales applied in this project.

Enrollment: 35
Study Start Date: September 2007
Study Completion Date: August 2011
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.
  2. Hamilton Depression Scale (21 items, HAM-D) total >16 with item 1 (depressed mood) >2.
  3. Age 18-70 years.
  4. Male or female.
  5. Competent and willing to give written informed consent.

Exclusion Criteria:

  1. Clinical hyper- or hypothyroidism or any other thyroid illness.
  2. Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
  3. Significant suicidal risk [HAM-D item 3 (suicide) >2].
  4. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
  5. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
  6. Treatment with the antidepressant, sertraline, in current episode.
  7. More then one antidepressant trial or any augmentation treatment during current episode.
  8. Length of current episode >12 months
  9. Female subjects pregnant or lactating or not using adequate contraception.
  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: NCT00421369

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Rena Cooper-Kazaz, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr. rena Cooper, HADASSAH MEDICAL ORGANIZATION
ClinicalTrials.gov Identifier: NCT00421369     History of Changes
Other Study ID Numbers: t3rbx-HMO-CTIL
Study First Received: January 11, 2007
Last Updated: March 21, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Major depressive disorder
Antidepressants
Triiodothyronine (T3)
Thyroid Function
Augmentation
Thyroid pathway genes

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Reboxetine
Sertraline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014