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Dopamine/serotonin dysbalance in dystonia.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23462
Enrollment
68
Registered
2010-01-22
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia Myoclonus/jerks Psychiatric co-morbidity (e.g. depression, anxiety disorders) Dystonie Myoclonieen of schokken Psychiatrische aandoeningen, zoals depressie en angsstoornissen

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 d

Sponsors

Academic Medical Center, University of Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients that change at least 1 point on Clinical Global Impression scale after treatment on jerks.

Secondary

MeasureTime frame
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.

Contacts

Public ContactMAJ Koning-Tijssen, de

Postbus 22660

M.A.Tijssen@amc.uva.nl+31 (0)20 5663842

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)