Tryptophan Depletion in Acute Mania

Bipolar Disorder Clinical Trial

Official title:

Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192725
• Other study ID #: tryp.dep.maniaCTIL
• Status: Completed
• Phase: N/A
• First received: September 11, 2005
• Last updated: August 24, 2010
• Start date: March 2003
• Est. completion date: June 2008

Study information

• Verified date: September 2005
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Acute mania

• Ability to provide written informed consent

Exclusion Criteria:

• Mixed affective states

• Suicidal ideation

• Uncontrolled systemic illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• rapid tryptophan depletion
Amino-acid mixture without tryptophan

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Beersheva Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Young Mania Rating Scale score		Before and after intervention	No
Secondary	Clinical Global Impression		Before and after intervention	No