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Sponsors and Collaborators: |
Rambam Health Care Campus Beersheva Mental Health Center |
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Information provided by: | Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT00192725 |
Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are currently the most widely used drugs for the treatment of depression. Patients with bipolar disorder (BD) who are treated for depression with SSRIs might develop mania, which is believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have clinical effects. However, RTD was not studied in acutely manic patients and could theoretically have antimanic properties. In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.
Condition | Intervention |
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Bipolar Disorder |
Other: rapid tryptophan depletion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ehud Klein, MD | 972-4-8542559 | e_klein@rambam.health.gov.il |
Israel | |
Rambam Medical Center | Recruiting |
Haifa, Israel, 31096 | |
Contact: Ehud Klein, MD 972-4-8542559 e_klein@rambam.health.gov.il | |
Principal Investigator: Yuval Ben-Amnon |
Principal Investigator: | Ehud Klein | Rambam Health Care Campus |
Study ID Numbers: | tryp.dep.maniaCTIL |
Study First Received: | September 11, 2005 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00192725 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
bipolar disorder acute mania tryptophan depletion placebo controlled add-on Bipolar disorder- manic type |
Tryptophan Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Psychotropic Drugs |
Mood Disorders Psychotic Disorders Antidepressive Agents, Second-Generation Antidepressive Agents |
Tryptophan Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Therapeutic Uses Psychotropic Drugs |
Mood Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |