DBT and Escitalopram in Borderline Personality Disorder | NCT00255554

Studies
DBT and Escitalopram in Borderline Personality Disorder

NCT00255554

Sponsor

Bronx VA Medical Center

Status

Unknown status

Last Update Posted

Nov 21, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavioral Therapy
Escitalopram

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

Nov 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 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

Nov 17, 2005

Last Update Posted Date

Nov 21, 2005Estimated

Description Module

Brief Summary

Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist. Half the subjects will concurrently receive escitalopram while half will receive placebo, in a randomized double-blind design.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has been off psychotropic medications for at least 2 weeks (6 weeks for fluoxetine).

Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation, current or recent Substance Dependence or a current Major Depressive Episode. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emily Hart	Contact	212-241-0441		mpgroup@mssm.edu

Overall Officials

Name	Affiliation	Role
Marianne Goodman, MD	Bronx VA Medical Center/Mount Sinai School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bronx VA Medical Center	Recruiting	The Bronx	New York	10029	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36375174	Derived	Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Name	Type	Description	Arm Group Labels	Other Names
Dialectical Behavioral Therapy	Behavioral
Escitalopram	Drug