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Tryptophan Depletion in Acute Mania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192725
First Posted: September 19, 2005
Last Update Posted: August 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beersheva Mental Health Center
Information provided by:
Rambam Health Care Campus
  Purpose
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
Bipolar Disorder Other: rapid tryptophan depletion

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

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

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

Estimated Enrollment: 40
Study Start Date: March 2003
Study Completion Date: June 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: rapid tryptophan depletion
    Amino-acid mixture without tryptophan
  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: September 11, 2005
First Posted: September 19, 2005
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