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Can Additional Drug Therapy Accelerate Response Time to Antidepressants

This study has been withdrawn prior to enrollment.
(PI move)
University of California, Los Angeles
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic Identifier:
First received: September 13, 2005
Last updated: May 29, 2015
Last verified: June 2006
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
Drug: citalopram + tiodothyronine, or + pindolol, or + placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Enrollment: 0
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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00221494

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

Responsible Party: Mark Frye, Principal Investigator, Mayo Clinic Identifier: NCT00221494     History of Changes
Other Study ID Numbers: 00-09-045-11
Study First Received: September 13, 2005
Last Updated: May 29, 2015

Keywords provided by Mayo Clinic:

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Serotonin Antagonists
Serotonin Agents
Vasodilator Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation processed this record on May 23, 2017