Bipolar Disorder
Conditions
Keywords
bipolar disorder, acute mania, tryptophan depletion, placebo controlled add-on, Bipolar disorder- manic type
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.
Interventions
OTHERrapid tryptophan depletion
Amino-acid mixture without tryptophan
Sponsors
Beersheva Mental Health Center
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute mania * Ability to provide written informed consent
Exclusion criteria
* Mixed affective states * Suicidal ideation * Uncontrolled systemic illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Young Mania Rating Scale score | Before and after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression | Before and after intervention |
Countries
Israel
Outcome results
None listed