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Search / Trial NCT03430596

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

Launched by SHANGHAI MENTAL HEALTH CENTER · Feb 6, 2018

Trial Information

Current as of June 06, 2025

Completed

Keywords

Extrapyramidal Syndromes Praminpexole Pilot Study

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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
  • Exclusion Criteria:
  • 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
  • 1. An adverse sffecr or serious adverse effect occured so that the intervention needs to be stopped
  • 2. Subjects with poor compliance or who didn't take drugs for 4 days
  • 3. Obvious plan violation ,or the safety codition and symptoms of the patients are deteriorating
  • 4. scored (mild) on at least two AIMS items or 3 (moderate) on one of the items are considered as tardive dyskesia
  • 5. Researcher's decision of the withdrawl of the subjects -

About Shanghai Mental Health Center

Shanghai Mental Health Center is a leading institution dedicated to advancing mental health research and treatment. As a prominent clinical trial sponsor, the center focuses on innovative therapeutic approaches and evidence-based practices to address a wide range of psychiatric disorders. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to enhancing patient care through rigorous clinical trials that contribute to the understanding and management of mental health conditions. Its mission is to foster collaboration among researchers, clinicians, and patients to promote mental well-being and improve outcomes in mental health care.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Huafang Li, MD,Phd

Principal Investigator

Drug Clinical Trial Office, Shanghai Mental Health Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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