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Tryptophan Depletion in Acute Mania

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ClinicalTrials.gov Identifier: NCT00192725
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 25, 2010
Sponsor:
Collaborator:
Beersheva Mental Health Center
Information provided by:
Rambam Health Care Campus

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Other: rapid tryptophan depletion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial
Study Start Date : March 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Tryptophan
U.S. FDA Resources


Intervention Details:
    Other: rapid tryptophan depletion
    Amino-acid mixture without tryptophan


Primary Outcome Measures :
  1. Reduction in Young Mania Rating Scale score [ Time Frame: Before and after intervention ]

Secondary Outcome Measures :
  1. Clinical Global Impression [ Time Frame: Before and after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute mania
  • Ability to provide written informed consent

Exclusion Criteria:

  • Mixed affective states
  • Suicidal ideation
  • Uncontrolled systemic illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192725


Locations
Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Beersheva Mental Health Center
Investigators
Principal Investigator: Ehud Klein Rambam Health Care Campus

Responsible Party: Ehud Klein, MD, Head Department of Psychiatry, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00192725     History of Changes
Other Study ID Numbers: tryp.dep.maniaCTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: September 2005

Keywords provided by Rambam Health Care Campus:
bipolar disorder
acute mania
tryptophan depletion
placebo controlled add-on
Bipolar disorder- manic type

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs