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Tryptophan Depletion in Acute Mania
This study is currently recruiting participants.
Verified by Rambam Health Care Campus, September 2005
First Received: September 11, 2005   Last Updated: October 1, 2007   History of Changes
Sponsors and Collaborators: Rambam Health Care Campus
Beersheva Mental Health Center
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00192725
  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

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

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Reduction in Young Mania Rating Scale score

Secondary Outcome Measures:
  • Clinical Global Impression

Estimated Enrollment: 40
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192725

Contacts
Contact: Ehud Klein, MD 972-4-8542559 e_klein@rambam.health.gov.il

Locations
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            
Sponsors and Collaborators
Rambam Health Care Campus
Beersheva Mental Health Center
Investigators
Principal Investigator: Ehud Klein Rambam Health Care Campus
  More Information

No publications provided

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

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

Study placed in the following topic categories:
Tryptophan
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Psychotropic Drugs
Mood Disorders
Psychotic Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009