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Tryptophan Depletion in Acute Mania

This study has been completed.
Sponsor:
Collaborator:
Beersheva Mental Health Center
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192725
First received: September 11, 2005
Last updated: August 24, 2010
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Tryptophan
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: Before and after intervention ] [ Designated as safety issue: No ]

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

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

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

No publications provided

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
Study First Received: September 11, 2005
Last Updated: August 24, 2010
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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Tryptophan
Antidepressive Agents, Second-Generation
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013