NCT00217165

Brief Summary

The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

4.8 years

First QC Date

August 22, 2005

Last Update Submit

February 26, 2019

Conditions

Bipolar DisorderManiaBipolar Depression

Keywords

bipolarmaniadepressiontaurinealternative

Outcome Measures

Primary Outcomes (1)

  • Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)

    MADRS and YMRS

    12 weeks

Secondary Outcomes (2)

  • Side-effect ratings, general health ratings

    12 weeks

  • Drop-outs due to medication changes

    12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

cellulose

Drug: taurine

active drug

ACTIVE COMPARATOR

taurine

Drug: taurine

Interventions

taurineDRUG

taurine 2mg BID po

active drugplacebo

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bipolar disorder, type I bipolar disorder, type II mania hypomania mixed manic symptoms

You may not qualify if:

  • significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar DisorderManiaDepression

Interventions

Taurine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Beth L Murphy, MD, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2005

First Posted

September 22, 2005

Study Start

April 1, 2005

Primary Completion

January 1, 2010

Study Completion

December 1, 2011

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

US(1)