The primary goal of the proposed study is to investigate the dopamine D2 receptor binding potential in patients with body dysmorphic disorder (BDD) and patients with trichotillomania (TTM) in comparison to healthy subjects. As BDD and TTM are OC…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is the total number of striatal D2 receptors. A ratio
will be calculated of radio-activity counts in the ROIs (striatal activity)
compared to the reference region (cortical activity).
Secondary outcome
no secundary study parameters
Background summary
Body dysmorphic disorder (BDD), also known as dysmorphophobia, consists of
preoccupation with an imagined defect of the appearance. Trichotillomania is a
disorder characterized by repetitive hair pulling, leading to noticeable hair
loss and functional impairment. Both disorders belong to the
obsessive-compulsive spectrum disorders and there is evidence suggesting
dopaminergic abnormalities in BDD and TTM. No neuroimaging research did
already involve the dopaminergic system in patients with BDD and TTM.
Study objective
The primary goal of the proposed study is to investigate the dopamine D2
receptor binding potential in patients with body dysmorphic disorder (BDD) and
patients with trichotillomania (TTM) in comparison to healthy subjects. As BDD
and TTM are OC spectrum disorders it is hypothesized that the mean D2 receptor
binding potential will be significantly lower in patients with BDD and TTM
compared to the comparison subjects. Because different allelles of the dopamine
receptor are involved in density and functional capacity of the dopamine
receptor, frequencies of the allelles of the dopamine receptor will be analyzed
in a blood sample.
Study design
An open, single dose study with 10 BDD patients, 10 TTM patients and 10 healthy
controls. The binding patterns of the radiolabeled IBZM will be investigated
with SPECT. Multi-modality imaging analysis will be used to define regions of
interest (ROIs) on the SPECT on the basis of a co-registered anatomic MRI-scan.
The radio-activity counts in the ROIs (striatal activity) will be used to
calculate ratios between the ROIs and the reference region (cortical activity).
The results of a previous study "IBZM single photon emission computed
tomography (SPECT) of dopamine D2 receptors in obsessive compulsive disorder"
at the University Medical Center Utrecht will be used for a comparison with
patients with obsessive compulsive disorder.
Study burden and risks
The radioligand 123I-IBZM, to be administered intravenously, is registered in
The Netherlands as radio-pharmaceutical. Until now no undesirable effects of
this radio-pharmaceutical were reported. The thyroid of the subject will be
blocked with potassium iodide in an oral dosage of 200 mg per day, starting 2
days prior to and on the day of administration of 123I-IBZM. The effective dose
equivalent (EDE) of 123I-IBZM is 0.034 mSv/MBq for an adult when using
saturated potassium iodide drops to block the thyroid. Therefore the total ED
for subjects participating in the study is expected to be no more than 6.0 mSv,
placing them in category IIb of the WHO (ICRP60).
Furthermore, two blood samples (2x 7cc) will be taken in order to determine the
genotype of the dopamine D2 region for each patient. Also, a MRI scan will be
performed. In case of brain abnormalities, patients will be informed and if
necessary adequate treatment will be started.
Meibergdreef 5
1100 DD Amsterdam
NL
Meibergdreef 5
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria: BDD patients and TTM patients:
- Physically healthy subjects
- Male and female, aged between 18-65 years
- Diagnosis of BDD by DSM -IV criteria, confirmed by the Structured Clinical Interview of DSM-IV
- Able to provide written informed consent and to comply with all study procedures.;Inclusion criteria: Control group
- Physically healthy subjects
- Male and female, aged between 18-65
- Absence of psychiatric DSM-IV axis I disorders, confirmed by the Structured Clinical Interview of
DSM-IV Axis Diagnoses (SCID)
- Absence of psychiatric DSM-IV axis II disorders, confirmed by the Structured Clinical Interview of
DSM-IV Axis Diagnoses (SCID)
- Able to provide written informed consent and to comply with all study procedures.
Exclusion criteria
Excusion criteria: BDD patients and TTM patients:
- Comorbidity of DSM-IV axis I disorders. In case of depressive symptoms, the score on the
Hamilton Depression Rating Scale (HDRS) should be less then 16
- Comorbidity of DSM-IV axis II disorders in cluster A or B ;Exclusion criteria: General
- Currently participating in an investigational study, or having participated in such a study within 30
days of their enrollment.
- Use of psychotropic medication within four weeks before the first test day.
- Drug or alcohol-abuse over a period of three weeks prior to the experiment. More then 15
cigarettes and more then 6 cups of caffeine containing coffee, cola or tea.
- A history of neurological illness or other medical problems potentially having central nervous
system sequellae.
- Pregnancy, breast feeding and use of inadequate anticonception.
- Use of other medication potentially influencing cerebral blood flow.
- Ongoing psychotherapy. Behavioral psychotherapy must be discontinued at least three months
before the first test day.
- Contraindications for MRI scan (claustrofobia, inclusion of metal components in the body, e.g.
pacemaker)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33001.018.10 |