Can Additional Drug Therapy Accelerate Response Time to Antidepressants
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: citalopram + tiodothyronine, or + pindolol, or + placebo (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Mark Frye Official(s) and/or principal investigator(s): Mark A Frye, MD, Principal Investigator, Affiliation: University of California, Los Angeles
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.
Clinical Details
Official title: Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
UCLA Neuropsychiatric Institute, Los Angeles, California 90095, United States
Additional Information
Starting date: January 2004
Last updated: May 29, 2015
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