Skip to main content
OpenTrials
Completed

NCT Number: NCT00192725

Tryptophan Depletion in Acute Mania

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical Center

Haifa, 31096, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute mania
  • Ability to provide written informed consent

Exclusion criteria

  • Mixed affective states
  • Suicidal ideation
  • Uncontrolled systemic illness

Treatment and study plan

rapid tryptophan depletion

Other

Amino-acid mixture without tryptophan

Primary outcomes

  1. Reduction in Young Mania Rating Scale score

    Time frame: Before and after intervention

Secondary outcomes

  1. Clinical Global Impression

    Time frame: Before and after intervention

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Beersheva Mental Health Center

Registry information

Official study title

Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.