Tardive dystonia
Conditions
Interventions
Active drug group: In the "
active drug group"
, a fixed daily dose of 0.375 mg of pramipexole extended-release tablet is administered to each patient for the first 4 weeks, after which physician can adjust the trial drug'
s dosage within the range of 0.375-1.50 mg per day, based on a clinical assessment. If the physician increases the dosage of the drug, the adjustment must be at an interval of at least 1 week. Maximum
usual care group"
, each patient'
s previous medication (such as anticholonergic agents) for tardive dystonia continues to be administered to the patient throughout the trial period of 16 weeks. The addition of any agent and/or adjust
s dosage are not allowed in this group.
Sponsors
Department of Psychiatry, Chiba University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this study, all of the following items must be met by the patient. 1) The patient's dystonia has been confirmed to have been caused by any agent with a blocking effect of dopamine receptor (i.e., tardive dystonia): the dystonia was not observed before the patient took the offending drug, and it emerged following medication with the drug for at least one month. 2) Medication with an anticholinergic agent (such as biperiden, trihexyphenidyl) at a sufficient dose has been provided at least once, but was not effective for the tardive dystonia. In addition, at the time that the patient's consent to participate in the study was obtained, the Global Assessment of Functioning score of the patient did not reach 60 points due to his/her dystonia and the symptoms caused the patient profound distress. 3) Within the 4 weeks before the patient's consent was obtained, the type and dosage of any psychotoropic drugs used were not changed. Occasional use of such drugs is accepted. 4) The patient's age at the time of consent is > 20 and < 60 years old. 5) The patient undestands all aspects of the study and gives written consent. If he/she is not able to understand the study due to his/her psychiatric disease, his/her representative gives written consent.
Exclusion criteria
Exclusion criteria: 1) With blepharospasm or oculogyric crisis alone as a symptom of tardive dystonia 2) Without a treatment history with anticholinergic agent 3) Under treatment with clozapine 4) With treatment histroy of deep brain stimulation (DBS) 5) With treatment history of electroconvulsove therapy (ECT) within 3 months prior to the study enrollment 6) With treatment history of botulinum toxin within 3 months prior to the study enrollment 7) Particition history of a clinical trial with any intervention ( i.e., except for observational study), within the most recent 3 months prior to the study enrollment 8) Without notification of a diagnosis of psychiatric disease 9) pregnant or childbearing-potential woman, and woman who are breast-feeding 10) With renal dysfunction: serum creatinine > 2.0 mg/dl 11) With hypersensitivity to any ingredient of the trial drug 12) With a suicide history within the most recent 1 year prior to the study enrollment 13) Assessed as unsuitable for participation in the study by the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Burke-Fahn-Marsden Dystonia Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Extrapyramidal Symptom Rating Scale(ESRS), Brief Psychiatric Rating Scale(BPRS), Euro Qol 5 demensions(EQ-5D) | — |
Countries
Japan
Contacts
Public ContactNobuhisa Kanahara
Chiba University Center for Forensic Mental Health Division of Medical Treatment and Rehabilitation
Outcome results
None listed