NCT00208702

Brief Summary

This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 1996

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

6.8 years

First QC Date

September 13, 2005

Last Update Submit

November 16, 2015

Conditions

Major Depression

Keywords

Major Depressive DisorderMental HealthDepression

Outcome Measures

Primary Outcomes (1)

  • MADRS score

Secondary Outcomes (1)

  • CGI

Study Arms (2)

sertraline + triiodothyronine

EXPERIMENTAL
Drug: TriiodothyronineDrug: Sertraline

sertraline + placebo

PLACEBO COMPARATOR
Other: PlaceboDrug: Sertraline

Interventions

TriiodothyronineDRUG
Also known as: Cytomel
sertraline + triiodothyronine
PlaceboOTHER
sertraline + placebo
SertralineDRUG
Also known as: Zoloft
sertraline + placebosertraline + triiodothyronine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
  • Primary diagnosis of unipolar Major Depressive Disorder
  • HAM-D (21 item) score \>18

You may not qualify if:

  • Alcohol abuse or alcohol dependence within the past year.
  • Psychoactive substance abuse or dependence within the past year.
  • Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
  • ECT within the past 6 months.
  • Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
  • Serious and unstable medical illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

  • Garlow SJ, Dunlop BW, Ninan PT, Nemeroff CB. The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder. J Psychiatr Res. 2012 Nov;46(11):1406-13. doi: 10.1016/j.jpsychires.2012.08.009. Epub 2012 Sep 7.

    PMID: 22964160RESULT

MeSH Terms

Conditions

Depressive Disorder, MajorPsychological Well-BeingDepression

Interventions

TriiodothyronineSertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPersonal SatisfactionBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Boadie W Dunlop, MD, MS

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Mood and Anxiety Disorders Program

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 1996

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(1)