a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    50
  • sponsor
    Shanghai Mental Health Center
Updated on 25 September 2021

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 ScaleBARS,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.

Details
Condition EXTRAPYRAMIDAL DISORDER
Treatment Pramipexole, Trihexyphenidyl hydrochloride, Trihexyphenidyl hydrochloride
Clinical Study IdentifierNCT03430596
SponsorShanghai Mental Health Center
Last Modified on25 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age from 18-65 years old, male or female
Subjects who met DSM-IV-TR criteria for extrapyramidal symptoms
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
Written informed consent provided by legal guardians or patients
Understand and voluntarily participate in this trail

Exclusion Criteria

A history of severe nervous system disease or nervous system injury 2 A
history of severe or unstable heart, liver, kidney, endocrine (including
thyroid function), hematological (such as those with hemorrhagic tendency)
condition 3 Subjects who have an imminent risk of suicideor who can be a
threat to himself others which judged by investigator 4 Substance or alcohol
dependence at enrolment 5 Pregnancy or lactation or willing to pregnant during
the trial 6 Low compliance to the doctor 7 Subjects who can't take drug in
time according to doctors' advice 8 scored (mild) on at least two AIMS items
or 3 (moderate) on one of the items are considered as tardive dyskesia
Withdrawl Criteria
An adverse sffecr or serious adverse effect occured so that the intervention needs to be stopped
Subjects with poor compliance or who didn't take drugs for 4 days
Obvious plan violation ,or the safety codition and symptoms of the patients are deteriorating
scored (mild) on at least two AIMS items or 3 (moderate) on one of the items are considered as tardive dyskesia
Researcher's decision of the withdrawl of the subjects -
Clear my responses

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