An Early Phase 1 interventional study of Pramipexole and Trihexyphenidyl hydrochloride in Extrapyramidal Syndrome, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Shanghai Mental Health Center · Early Phase 1, Interventional, and Treatment
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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.
40 studies on the registry are indexed under Basal Ganglia Diseases; 13 are open to participants now.
This study's enrollment of 50 is close to the median of 52 across 31 interventional studies indexed under Basal Ganglia Diseases.
Browse Basal Ganglia Diseases studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pramipexole ,flexible dose (0.375mg/d-0.75mg/d)
Drug: Pramipexole
Antan,flexible dose (2-4mg/d)
Drug: Trihexyphenidyl hydrochloride
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 .
Also known as: SenForro
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 .
Also known as: Antan
The change of SAS BARS AIMS from baseline
To compare the condition of the extrapyramidal symptoms between two groups
Time frame: 8 weeks
The change of PANSS CDSS CGI-S from baseline
To compare the change of the symptoms of chziophrenia between two groups
Time frame: 8 weeks
Ran from May 2018 to primary completion in Oct 2021, 41 months.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pramipexole
Shanghai Mental Health Center →