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

NCT03430596 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-27

No results posted yet for this study

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.

Conditions

  • Extrapyramidal Syndrome

Interventions

DRUG

Pramipexole

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 .

DRUG

Trihexyphenidyl 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 & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Huafang Li, MD,Phd · Drug Clinical Trial Office, Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-10-30
Completion
2021-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430596 on ClinicalTrials.gov