Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-C... | NCT00217165

Studies
Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study

NCT00217165

Sponsor

Mclean Hospital

Status

Completed

Last Update Posted

Mar 1, 2019Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Bipolar Disorder
Mania
Bipolar Depression

Interventions

taurine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Jan 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 22, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 17, 2017

Certification/Extension First Submitted that Passed QC Review

Mar 17, 2017

Certification/Extension First Posted Date

Mar 20, 2017Actual

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Mar 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beth L. Murphy MD, PhD, Principal Investigator, Mclean HospitalPrincipal Investigator

Lead Sponsor

Mclean HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Taurine is an amino acid that has some actions similar to mood stabilizers. Taurine is widely sold as a component of over-the-counter mood enhancing agents. However, controlled studies examining the mood effects of taurine are limited. An initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. This follow-up study is designed to further examine taurine's effects on manic symptoms. Subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. Both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	cellulose	Drug: taurine
active drug	Active Comparator	taurine	Drug: taurine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
taurine	Drug	taurine 2mg BID po	active drug placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)	MADRS and YMRS	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Side-effect ratings, general health ratings	SF36	12 weeks
Drop-outs due to medication changes	subjects leaving study before completion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beth L Murphy, MD, PhD	Mclean Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McLean Hospital		Belmont	Massachusetts	02478	United States

References Module

Citations

Not provided

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations

ID	Term
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons

ID	Term
D001714	Bipolar Disorder
D000087122	Mania
D003863	Depression