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NCT Number: NCT03430596

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

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.

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Key information

Conditions

Extrapyramidal Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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 -

Treatment and study plan

Pramipexole

Drug

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 .

Other names: SenForro

Trihexyphenidyl hydrochloride

Drug

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 .

Other names: Antan

Primary outcomes

  1. The change of SAS BARS AIMS from baseline

    Time frame: 8 weeks

    To compare the condition of the extrapyramidal symptoms between two groups

Secondary outcomes

  1. The change of PANSS CDSS CGI-S from baseline

    Time frame: 8 weeks

    To compare the change of the symptoms of chziophrenia between two groups

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2018
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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