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CompletedNCT00204347Updated Jun 10, 2021

Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder

A Phase 4 interventional study of risperidone in Borderline Personality Disorder, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
19 Years and older
Sex
Female
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Study summary

The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).

Read the detailed description

Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen.

Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.

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Conditions studied

  • Borderline Personality Disorder

Keywords

  • risperidone
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In context

Personality Disorders

336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.

This study's enrollment of 20 is below the median of 75 across 229 interventional studies indexed under Personality Disorders.

Browse Personality Disorders studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diagnosis of BPD

Exclusion criteria

Exclusion Criteria:

  • Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

  • Drugrisperidone
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What researchers measure

Primary outcomes

  1. Clinical Global Impression

  2. Brief Symptom Inventory

Secondary outcomes

  1. Beck Depression Inventory

  2. Quality of Life Enjoyment and Satisfaction Questionnaire

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Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35205, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00204347
Lead sponsor
University of Alabama at Birmingham
Collaborators
Janssen Pharmaceutica
Responsible party
Roberta May (Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Sep 20, 2005
Start date
Jul 2003
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Jun 10, 2021

Study contacts

Celia T. Huston, PhD
principal investigator · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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