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Clinical Trials/EUCTR2018-001212-30-DE
EUCTR2018-001212-30-DE
Active, not recruiting
Phase 1

A trial to study effects of a single dose Citalopram on emotion processing in female patients with Borderline Personality Disorder and the associated modulation of fMRI BOLD signals

Central Institute of Mental Health, represented by commercial and administrative Director0 sites30 target enrollmentJuly 23, 2018
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ConditionsBorderline Personality DisorderMedDRA version: 20.0 Level: PT Classification code 10006034 Term: Borderline personality disorder System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsCitalopram

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Central Institute of Mental Health, represented by commercial and administrative Director
Enrollment
30
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 23, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Central Institute of Mental Health, represented by commercial and administrative Director

Eligibility Criteria

Inclusion Criteria

  • •?Healthy, female, aged 18\-45 years
  • •?Diagnosis of Borderline Personality Disorder according to DSM\-IV
  • •?Use of adequate contraception
  • •?Fluent German speaker and capable of completing the fMRI and behavioural tasks
  • •?Signed written informed consent prior to the first study related procedure
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •?A history of alcohol or substance dependence within last 12 months prior to Visit 1
  • •?A positive urine drug screen at Visit 1 (one re\-test permitted within 1\-3 days)
  • •?A positive alcohol breath test at Visit 1
  • •?A positive pregnancy test at visit 1
  • •?Currently pregnant or trying to get pregnant or currently breast feeding
  • •?Consumption of large amounts of caffeinated drinks (\> 8 cups of standard caffeinated drinks or \> 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day)
  • •? Blood pressure outside normotensive range (systolic: 90 \- 150 mm Hg, diastolic: 60 \- 90 mm Hg ) at Visit 1
  • •? Heart rate \= 50 beats per minute at Screening
  • •? Abnormal ECG, including QTcF \> 470 ms (women) based on the Fridericia correction where QTcF \= QT/RR0\.33
  • •? Left\-handed

Outcomes

Primary Outcomes

Not specified

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