To investigate if jerks and psychiatric disorders in patients with dystonia are associated with a hyperdopaminergic/ hyposerotonergic system and whether reversal of a hyposerotonergic state has a therapeutic effect.
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
Synonym
Health condition
depressie, angst- en dwangstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage difference in dopamine D2 receptor, dopamine transporter and
serotonin transporter binding between subjects with dystonia and healthy
controls.
Proportion of patients that change at least 1 point on CGI scale after
treatment on jerks.
Secondary outcome
The proportion of dystonia patients with jerks that have psychiatric
co-morbidity compared to dystonia patients without jerks
Type of psychiatric co-morbidity in dystonia patients.
Performance on neuropsychological tests in dystonia patients.
Percentage difference in D2R, DAT and SERT binding between subjects with
dystonia with and without jerks and with and without psychiatric disorders.
Percentage change in D2R, DAT and SERT binding in subjects with dystonia before
and after a 6 week treatment course with an SSRI.
Number of points change on CGI scale before and after treatment on psychiatric
symptoms and dystonia.
Number of points change on neurological and psychological scales.
Background summary
There are several clues that dystonia, and co-morbid myoclonus and psychiatric
conditions, are caused by a dysbalanced dopaminergic and serotonergic system.
In this project, we will test this hypothesis. This project will contribute to
the knowledge about the pathophysiology of dystonia and may point to new
therapeutic options in patients with dystonia.
Study objective
To investigate if jerks and psychiatric disorders in patients with dystonia are
associated with a hyperdopaminergic/ hyposerotonergic system and whether
reversal of a hyposerotonergic state has a therapeutic effect.
Study design
This study consists of two parts: SPECT imaging of the dopaminergic and
serotonergic systems and a randomized, double-blind, placebo-controlled,
crossover trial with escitalopram, an SSRI.
Intervention
Escitalopram 10 mg will be administered for 6 weeks in a randomized,
placebo-controlled, double-blind, crossover trial with a washout period of 6
weeks.
Study burden and risks
The nature and extent of the burden depend on which parts of the study patients
participate in. Patients will undergo a neurological and psychiatric evaluation
two to four times. Patients that participate in the SPECT study will undergo
two times two SPECT scans. Healthy controls participating in the SPECT study
will also be neurologically and psychiatrically evaluated and will undergo two
SPECT scans. Patients participating in the medication trial will have to take
medication, escitalopram and placebo, each for 6 weeks. They will undergo 2
venapunctions with the withdrawing of 5 mL blood. The burden of this study can
vary between four visits and 6 visits in 18 weeks.
The risks associated with participation in these studies are low: the
psychiatric questionnaires used in our studies are considered to be mildly
psychologically stressful. SPECT is a safe imaging technique with acceptable
radiation dose. Escitalopram is a widely used drug with little side effects. In
the long term this study may lead to new treatment options for patients with
dystonia.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age between 35 and 80 years old
Primary generalized, segmental or focal dystonia with or without jerks
Informed consent
Botulinum toxin injections in the Academic Medical Center
Stable Tsui scale for severity of dystonia for at least one year
Exclusion criteria
Other neurological conditions at inclusion or in the past
Treatment with deep brain stimulation for dystonia
SSRI use in the past 6 months prior to or during the study
Use of other anti-depressants during the study, especially MAO-B inhibitors
Symptomatic therapy for dystonia other than botulinum toxin, e.g. baclofen or other muscle relaxants.
Use of medication with a known effect on dopamine or serotonin receptors or transporters or with a known interaction with escitalopram (e.g. L-DOPA, dopamine-agonists, ritalin, NSAID*s, aspirin, tryptophan, carbamazepine, etcetera)
Pregnancy or nursing
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-018016-25-NL |
| ClinicalTrials.gov | NCT2178 |
| CCMO | NL31453.018.10 |