Tryptophan Depletion in Acute Mania
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
rapid tryptophan depletion
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, acute mania, tryptophan depletion, placebo controlled add-on, Bipolar disorder- manic type
Eligibility Criteria
Inclusion Criteria: Acute mania Ability to provide written informed consent Exclusion Criteria: Mixed affective states Suicidal ideation Uncontrolled systemic illness
Sites / Locations
- Rambam Medical Center
Outcomes
Primary Outcome Measures
Reduction in Young Mania Rating Scale score
Secondary Outcome Measures
Clinical Global Impression
Full Information
NCT ID
NCT00192725
First Posted
September 11, 2005
Last Updated
August 24, 2010
Sponsor
Rambam Health Care Campus
Collaborators
Beersheva Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00192725
Brief Title
Tryptophan Depletion in Acute Mania
Official Title
Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Beersheva Mental Health Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, acute mania, tryptophan depletion, placebo controlled add-on, Bipolar disorder- manic type
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
rapid tryptophan depletion
Intervention Description
Amino-acid mixture without tryptophan
Primary Outcome Measure Information:
Title
Reduction in Young Mania Rating Scale score
Time Frame
Before and after intervention
Secondary Outcome Measure Information:
Title
Clinical Global Impression
Time Frame
Before and after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute mania
Ability to provide written informed consent
Exclusion Criteria:
Mixed affective states
Suicidal ideation
Uncontrolled systemic illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehud Klein
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
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Tryptophan Depletion in Acute Mania
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