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
- Conditions
- Borderline 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]
- Registration Number
- EUCTR2018-001212-30-DE
- Lead Sponsor
- Central Institute of Mental Health, represented by commercial and administrative Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
?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
F.1.3.1 Number of subjects for this age range
?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
? Smoking = 20 cigarettes per day
? BMI (weight [kg]/height [m]²) outside range of 18 to 35 kg/m²
? Relevant history, or presence upon clinical examination of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures
?History of cancer, except for basal cell or Stage 1 squamous cell carcinoma of skin which is in remission for at least 5 years prior to study Visit 1
?Meeting the diagnostic criteria for a psychotic disorder or schizophrenia, as determined by the SCID-I at Visit 1
?Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack)
?A history of positive HIV test
?Medical history of cranial surgery
?Significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which might interfere with the performance of the behavioural tasks or fMRI tasks
?Treatment with psychotropic medication within 28 days prior to Visit 1 (except medication received will not interfere with the study procedures or compromise safety in opinion of investigator)
?Treatment with experimental drug and / or experimental medical device within 30 days of randomisation or within a period less than 5 times the drug’s half-life, whichever is longer
?Known hypersensitivity to Citalopram or any of their excipients.
?History of severe drug allergy or hypersensitivity
?Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
?History of claustrophobia or inability to tolerate scanner environment
?Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
?Clinically relevant structural brain abnormality as determined by prior MRI scan
?Planned medical treatment within the study period that might interfere with the study procedures.
?Staff member
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of a single dose of Citalopram (20 mg) compared to placebo on BOLD responses on the amygdala and related brain structures induced by emotional stimuli using functional Magnetic Resonance Imaging (fMRI) in un-medicated female participants with Borderline Personality Disorder.;Secondary Objective: ;<br> Primary end point(s): Altered BOLD response amplitude in the OASIS paradigm in the following brain regions:<br> ?Amygdala left<br> ?Amygdala right<br> ?Dorsolateral Prefrontal cortex left<br> ?Dorsolateral Prefrontal cortex right<br> ?Insula left<br> ?Insula right<br> ?Anterior cingulate cortex left<br> ?Anterior cingulate cortex right<br> ;Timepoint(s) of evaluation of this end point: at Treatment visits day 7 and day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Altered BOLD response amplitude (BOLD fMRI), functional connectivity, or blood flow (ASL-MRI) in other paradigms and/or other brain regions;Timepoint(s) of evaluation of this end point: at Treatment visits day 7 and day 14