Extrapyramidal Syndrome
Conditions
Keywords
Extrapyramidal syndromes praminpexole pilot study
Brief summary
This study is a pilot phased interventional clinical trial . The first stage will recruit 10 patients with antipsychotic induced extrapyramidal symptoms.The patients will take pramipexole for 8 weeks. The inital dose of pramipexole will be 0.375 mg/d, and the adjustment of drug dose will be depended on the the doctor's decision and patients' condition. The second stage was a randomized, rater blindness and Antan controlled clinical study. Researchers will recruit another 40 patients with extrapyramidal symptoms (tradive dyskinesia will be excluded). The patients will randomly be divided into artane group or pramipexole group, and the efficacy and safety condition of pramipexole and artane for different kinds of EPS will be compared. The pramipexole group will have 20 cases, and 20 cases of artane group. The dose of pramipexole group group range from 0.375mg/d to 0.75mg/d dose .The dose of artane range from 2 mg/d to 4 mg/d,.The accurate drug doses can be adjusted by the doctor according to the patients' condition . Researchers will evualate patients' symptom at baseline, after three days' of baseline, 2 weeks,4 weeks, 6 weeks and 8 weeks. The Simpson-Angus Scale(SAS) 、Barnes Akathisia Rating Scale（BARS）,Abnormal Involuntary Movement Scale (AIMS), Positive and Negative Syndrome Scale(PANSS), Calgary Depression Scale for Schizophrenia(CDSS), Clinical Global Impression-severity of Illness Scale(CGI-S) will be evualated by the trained raters indicated as the drug's efficacy of the extrapyramidal symptoms and schizophrenia .The adverse events, laboratory parameters, vital signs, ECG will be recorded as the safety indicators of the study drugs.
Interventions
DRUGPramipexole
The dose of pramipexole range from 0.375mg/d to 0.75mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
DRUGTrihexyphenidyl hydrochloride
he dose of Antan range from 2 mg/d to 4 mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18-65 years old, male or female 2. Subjects who met DSM-IV-TR criteria for extrapyramidal symptoms 3. Scored 1 (mild) on at least two SAS items or 2 (moderate) on one of the items
Exclusion criteria
are considered as antipsychotic induced parkinson ; Scored at least 2 (mild) on the BARS global item are considered as antipsychotic induced akathisia 4. Written informed consent provided by legal guardians or patients 5. Understand and voluntarily participate in this trail
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of SAS BARS AIMS from baseline | 8 weeks | To compare the condition of the extrapyramidal symptoms between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of PANSS CDSS CGI-S from baseline | 8 weeks | To compare the change of the symptoms of chziophrenia between two groups |
Countries
China
Outcome results
None listed