NCT00221494

Brief Summary

Antidepressants are commonly prescribed and are effective for treating depression. However, they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether simultaneous treatment with thyroid hormone or pindolol can decrease the response time ("getting better faster") in patients who are starting SSRI treatment.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

June 1, 2015

Status Verified

June 1, 2006

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

May 29, 2015

Conditions

Depression

Keywords

depression

Interventions

citalopram + tiodothyronine, or + pindolol, or + placeboDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, male and female, between the ages of 18 to 65
  • DSM-IV criteria for major depressive disorder
  • No prior SSRI medication treatment (if a patient has discontinued a non-SSRI medication for side effects, they will not be excluded)
  • Ability to be followed clinically for 6 weeks
  • Each patient must understand the nature of the study and must sign an informed consent form

You may not qualify if:

  • Severe suicidality (as defined by Beck Depression Inventory Question 9, responses 2 or 3)
  • Major Axis I mental illness other than major depressive disorder
  • Unstable medical health specifically cardiovascular disease, abnormal EKG, history of severe drug allergy, poorly controlled diabetes, and asthma (pindolol contraindication)
  • History of thyroid disease or abnormal TFT's (stage I or II)
  • Need for adjunctive antipsychotic use or additional benzodiazepine during the study
  • Pregnancy
  • Seizure disorder
  • A positive urine toxicology screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Depression

Interventions

CitalopramPindolol

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanols

Study Officials

  • Mark A Frye, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Primary Completion

June 1, 2006

Last Updated

June 1, 2015

Record last verified: 2006-06

Locations

US(1)