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

NCT00421369 | Completed

• 1 other identifier: t3rbx-HMO-CTIL
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Antidepressants; Triiodothyronine (T3); Thyroid Function; Augmentation; Thyroid pathway genes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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.

Interventions

sertraline DRUG

triiodothyronine (T3) DRUG

reboxetine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline; Triiodothyronine; Reboxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rena Cooper-Kazaz, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 12, 2007
• Study Start: September 1, 2007
• Study Completion: August 1, 2011
• Last Updated: March 22, 2013

Record last verified: 2007-01

Locations

IL (1)