Status:
COMPLETED
a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Extrapyramidal Syndrome
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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....
Eligibility Criteria
Inclusion
- 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
- 1 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 -
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03430596
Start Date
May 1 2018
End Date
December 30 2021
Last Update
June 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030