Can Additional Drug Therapy Accelerate Response Time to Antidepressants
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | January 8, 2009 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00221494 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Can Additional Drug Therapy Accelerate Response Time to Antidepressants | ||||
| Official Title ICMJE | Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-Blind, Placebo-Controlled Randomization Research Study for Major Depression | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Drug: citalopram + tiodothyronine, or + pindolol, or + placebo | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00221494 | ||||
| Other Study ID Numbers ICMJE | 00-09-045-11 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||
| Verification Date | June 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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