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Can Additional Drug Therapy Accelerate Response Time to Antidepressants

This study has been withdrawn prior to enrollment.
(PI move)
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00221494
First received: September 13, 2005
Last updated: January 8, 2009
Last verified: June 2006

September 13, 2005
January 8, 2009
January 2004
June 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00221494 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depression
Drug: citalopram + tiodothyronine, or + pindolol, or + placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00221494
00-09-045-11
Yes
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University of California, Los Angeles
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Principal Investigator: Mark A Frye, MD University of California, Los Angeles
University of California, Los Angeles
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP