Dopamine-serotonin dysbalance and the relation to myoclonus and psychiatric co-morbidity in patients with dystonia

Phase 3

Completed

• Conditions: depressie, angst- en dwangstoornissen; Disturbed muscle tension; 10028037

• Registration Number: NL-OMON34645
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 83

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage difference in dopamine D2 receptor, dopamine transporter and<br /><br>serotonin transporter binding between subjects with dystonia and healthy<br /><br>controls.<br /><br>Proportion of patients that change at least 1 point on CGI scale after<br /><br>treatment on jerks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The proportion of dystonia patients with jerks that have psychiatric<br /><br>co-morbidity compared to dystonia patients without jerks<br /><br>Type of psychiatric co-morbidity in dystonia patients.<br /><br>Performance on neuropsychological tests in dystonia patients.<br /><br>Percentage difference in D2R, DAT and SERT binding between subjects with<br /><br>dystonia with and without jerks and with and without psychiatric disorders.<br /><br>Percentage change in D2R, DAT and SERT binding in subjects with dystonia before<br /><br>and after a 6 week treatment course with an SSRI.<br /><br>Number of points change on CGI scale before and after treatment on psychiatric<br /><br>symptoms and dystonia.<br /><br>Number of points change on neurological and psychological scales.</p><br>