Can Additional Drug Therapy Accelerate Response Time to Antidepressants

Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression
• Intervention / Treatment: Drug: citalopram + tiodothyronine, or + pindolol, or + placebo

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Neuropsychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Mark Frye
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Mark A Frye, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin Antagonists; Antidepressive Agents, Second-Generation; Citalopram; Pindolol
• Other Study ID Numbers: 00-09-045-11