|- candidate number||6908|
|- NTR Number||NTR2178|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jan-2010|
|- Secondary IDs||2009-018016-25 EudraCT|
|- Public Title||Dopamine/serotonin dysbalance in dystonia.|
|- Scientific Title||Dopamine/serotonin dysbalance and the relation to myoclonus and psychiatric co-morbidity in patients with dystonia.|
|- Healt Condition(s) or Problem(s) studied||Mental illness, Dystonia, Myoclonus|
|- Inclusion criteria||1. Age between 18 and 80 years old;|
2. Informed consent;
3. Primary dystonia treated with botulinum toxin injections in the Academic Medical Center;
4. Stable Tsui scale for severity of dystonia for at least one year.
|- Exclusion criteria||1. Other neurological conditions at inclusion or in the past;|
2. Use of medication or drugs with a known effect on the execution of tasks, besides anti-epileptic drugs;
3. Treatment with deep brain stimulation for dystonia;
4. SSRI use in the past 6 months prior to or during the study;
5. Use of other anti-depressants during the study, especially MAO-B inhibitors;
6. Symptomatic therapy for dystonia other than botulinum toxin;
7. Use of medication with a known effect on dopamine or serotonin receptors or transporters or with a known interaction with escitalopram;
8. Pregnancy or nursing.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2010|
|- planned closingdate||1-apr-2013|
|- Target number of participants||68|
|- Interventions||Subjects are randomly assigned to first receive one of the following treatment regimens for a period of 6 weeks:|
1. Escitalopram 10 mg tablets orally;
2. Placebo tablets orally.
After a washout period of 6 weeks the interventions will be switched: the patients who received escitalopram will receive placebo and vice versa. Because of the crossover design every patient will be his own control.
During the medication trial subjects will be neurologically and psychiatrically examined 4 times. Effects of escitalopram and placebo treatment will be compared.
|- Primary outcome||Proportion of patients that change at least 1 point on Clinical Global Impression scale after treatment on jerks.
|- Secondary outcome||1. Type of psychiatric co-morbidity in dystonia patients;|
2. Number of points change on CGI scale before and after treatment on psychiatric symptoms and dystonia;
3. Number of points change on neurological and psychological scales.
|- Timepoints||Subjects will be neurologically and psychiatrically evaluated 4 times during the trial (before and after each treatment round). Results of escitalopram and placebo treatment will be compared at the end of the study, when the randomization code is broken.|
An interim analysis will be carried out by an independent statistician after 35 patients completed the first treatment round.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. MAJ Koning-Tijssen, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MAJ Koning-Tijssen, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Rationale:|
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
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.
This study consists of three parts: randomized, double-blind, placebo-controlled, crossover trial with escitalopram, an SSRI.
Patients with dystonia with and without jerks.
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.
Main study parameters/endpoints:
Proportion of patients that change at least 1 point on CGI scale after treatment on jerks.
Nature and extent of the burden and risks associated with participation, benefit and
Patients will undergo a neurological, neuropsychological and psychiatric evaluation four times. Subjects 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 consists of 2 visits in 18 weeks.
The risks associated with participation in these studies are low: the psychiatric questionnaires used in our study are considered to be mildly psychologically
stressful. 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.
|- Main changes (audit trail)|
|- RECORD||22-jan-2010 - 29-apr-2017|