NCT00192725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 25, 2010

Status Verified

September 1, 2005

Enrollment Period

4.6 years

First QC Date

September 11, 2005

Last Update Submit

August 24, 2010

Conditions

Bipolar Disorder

Keywords

bipolar disorderacute maniatryptophan depletionplacebo controlled add-onBipolar disorder- manic type

Outcome Measures

Primary Outcomes (1)

  • Reduction in Young Mania Rating Scale score

    Before and after intervention

Secondary Outcomes (1)

  • Clinical Global Impression

    Before and after intervention

Interventions

rapid tryptophan depletionOTHER

Amino-acid mixture without tryptophan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute mania
  • Ability to provide written informed consent

You may not qualify if:

  • Mixed affective states
  • Suicidal ideation
  • Uncontrolled systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Ehud Klein

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

March 1, 2003

Primary Completion

October 1, 2007

Study Completion

June 1, 2008

Last Updated

August 25, 2010

Record last verified: 2005-09

Locations

IL(1)