Natural Supplements for Unipolar Depression | NCT00226356

Studies
Natural Supplements for Unipolar Depression

NCT00226356

Sponsor

Cambridge Health Alliance

Status

Completed

Last Update Posted

Apr 18, 2017Actual

Enrollment

20Actual

Phase

Phase 4

Conditions

Unipolar Depression

Interventions

Supplements of L-methionine, betaine and folate

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

Apr 2017

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

Dec 2004

Primary Completion Date

Jun 2007Actual

Completion Date

Sep 17, 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 27, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2017

Last Update Posted Date

Apr 18, 2017Actual

Name	Class
National Alliance for Research on Schizophrenia and Depression	OTHER

Description Module

Brief Summary

This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.

Detailed Description

The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplements of L-methionine, betaine and folate	Experimental		Drug: Supplements of L-methionine, betaine and folate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supplements of L-methionine, betaine and folate	Drug		Supplements of L-methionine, betaine and folate

Measure	Description	Time Frame
Depressive symptoms

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV diagnosis of a MDD or DDNOS; clinical indication for treatment of current depressive symptoms; HDS > 18; women of reproductive potential must use an acceptable method of birth control

Exclusion Criteria:

Treatment with another psychotropic drug; history of mania or hypomania; history of bipolar illness in first-degree relatives; active homicidality; pregnant; trying to become pregnant, or nursing; unstable medical condition; current substance abuse in the past month; history of sulfa allergy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert T Dunn, MD, PhD	Cambridge Health Alliance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cambridge Health Alliance		Cambridge	Massachusetts	02139	United States

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001622	Betaine
D005492	Folic Acid

Ancestor Terms

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided