a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.