Borderline Personality Disorders Clinical Trial
Official title:
An fMRI Study of the Enhancement of Emotion Regulation in Borderline Patients
Verified date | October 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has proven quite treatment resistant. This study is designed to determine whether patients with BPD can be trained to improve their ability to regulate their emotions and whether this leads to changes in how their brans regulate emotion.
Status | Completed |
Enrollment | 169 |
Est. completion date | September 21, 2017 |
Est. primary completion date | September 21, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - BPD subjects 18 to 50 years old - Meet criteria for DSM-IV Borderline Personality Disorder, including the DSM-IV criteria for affective instability (criterion #6), and not meet criteria for Schizotypal Personality Disorder (SPD) or AvPD. - Subjects in the AvPD group meet DSM-IV criteria for AvPD and not for BPD or SPD. - All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine). - Subjects may be enrolled in psychotherapy Exclusion Criteria: - BPD and AvPD subjects will not meet DSM-IV criteria for past or present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression. - Substance abuse disorder in the prior 6 months - Significant medical illness - Pregnancy - Metallic foreign-bodies that contraindicate MRI |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in BOLD signal in brain | BOLD signal changes at 5 days compared to baseline to measure reappraisal success using fMRI to record brain activity. | baseline and 5 days | |
Primary | Changes in BOLD signal in brain | BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity. | baseline and 2 weeks | |
Secondary | Perceived Stress Scale | Change in Perceived Stress Scale at 5 days compared to baseline | baseline and 5 days | |
Secondary | Perceived Stress Scale | Change in Perceived Stress Scale at 2 weeks compared to baseline | baseline and 2 weeks | |
Secondary | State Trait Anger Expression Inventory (STAXI) | Change in STAXI at 5 days compared to baseline | baseline and 5 days | |
Secondary | State Trait Anger Expression Inventory (STAXI) | Change in STAXI at 2 weeks compared to baseline | baseline and 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Unknown status |
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A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
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N/A | |
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