Tryptophan Depletion in Acute Mania
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00192725
- Lead Sponsor
- Rambam Health Care Campus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Acute mania
- Ability to provide written informed consent
- Mixed affective states
- Suicidal ideation
- Uncontrolled systemic illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in Young Mania Rating Scale score Before and after intervention
- Secondary Outcome Measures
Name Time Method Clinical Global Impression Before and after intervention
Trial Locations
- Locations (1)
Rambam Medical Center
🇮🇱Haifa, Israel