Full Text View
Tabular View
No Study Results Posted
Related Studies
Can Additional Drug Therapy Accelerate Response Time to Antidepressants
This study has been withdrawn prior to recruitment.
( PI move )
First Received: September 13, 2005   Last Updated: January 8, 2009   History of Changes
Sponsored by: University of California, Los Angeles
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00221494
  Purpose

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.


Condition Intervention Phase
Depression
Drug: citalopram + tiodothyronine, or + pindolol, or + placebo
Phase IV

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Pindolol Citalopram
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-Blind, Placebo-Controlled Randomization Research Study for Major Depression

Further study details as provided by University of California, Los Angeles:

Study Start Date: January 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe suicidality (as defined by Beck Depression Inventory Question 9, responses 2 or 3)
  2. Major Axis I mental illness other than major depressive disorder
  3. Unstable medical health specifically cardiovascular disease, abnormal EKG, history of severe drug allergy, poorly controlled diabetes, and asthma (pindolol contraindication)
  4. History of thyroid disease or abnormal TFT's (stage I or II)
  5. Need for adjunctive antipsychotic use or additional benzodiazepine during the study
  6. Pregnancy
  7. Seizure disorder
  8. A positive urine toxicology screen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221494

Locations
United States, California
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Mark A Frye, MD University of California, Los Angeles
  More Information

No publications provided

Study ID Numbers: 00-09-045-11
Study First Received: September 13, 2005
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00221494     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
depression

Study placed in the following topic categories:
Pindolol
Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:
Depression
Mental Disorders
Therapeutic Uses
Psychotropic Drugs
Mood Disorders
Depressive Disorder
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 06, 2009