search
Back to results

Can Additional Drug Therapy Accelerate Response Time to Antidepressants

Primary Purpose

Depression

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
citalopram + tiodothyronine, or + pindolol, or + placebo
Sponsored by
Mark Frye
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • UCLA Neuropsychiatric Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 29, 2015
Sponsor
Mark Frye
Collaborators
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT00221494
Brief Title
Can Additional Drug Therapy Accelerate Response Time to Antidepressants
Official Title
Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Withdrawn
Why Stopped
PI move
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Frye
Collaborators
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Major depression is an illness with substantial personal and economic morbidity (Greenberg et al.1993) and antidepressants are the cornerstone of treatment. As antidepressants usually require 3-6 weeks of use before a response occurs, an effective antidepressant acceleration strategy would reduce the time of onset for an effective antidepressant response. This has significant clinical implications, as it could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life. The goal of this study is to enhance our understanding of strategies that accelerate or produce a more rapid treatment response in depression. This could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life. The study goals are: 1.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can accelerate the treatment response (i.e. faster rate of improvement), 2.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can augment or enhance treatment response (i.e. greater reduction in depressive symptoms at end of study phase), adn 3.) To assess whether gender influences the acceleration of augmentation response rate of liothyronine or pindolol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
citalopram + tiodothyronine, or + pindolol, or + placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Frye, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Can Additional Drug Therapy Accelerate Response Time to Antidepressants

We'll reach out to this number within 24 hrs