Guided Dose Reduction of Antipsychotic in Patients With Psychosis in Remitted States (GDR)
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|ClinicalTrials.gov Identifier: NCT03248180|
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Impact of Guided Antipsychotic Dose Reduction in Patients With Psychosis Under Remitted States: a Randomized Control Trial and Prospective Follow-up Study|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Guided dose reduction (GDR)
Patients in the GDR group will be advised to reduce < 25% of their current dose of antipsychotic agents estimated on a weekly base and follow-up every 4 weeks for at least 12 weeks.
Maintenance treatment group (MTG)
Patients in the MTG will be advised to stay on their current dose of antipsychotics throughout the observational period, follow-up every 12 weeks.
- Relapse of psychosis defined by worsening of scores in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: up to 2 years ]Patients will be measured with a Positive and Negative Syndrome Scale (PANSS) every 4 weeks for 3 times (during 12 weeks) if conducting dose reduction or every 12 weeks if staying on the same dose to observe if any worsening of symptoms. Patient has a PANSS score > 4 in any item of those 3 positive symptoms (P1: delusion, P2: conceptual disorganization, P3: hallucination) and 2 general symptoms (G9: unusual thought, G5:mannerism and posturing) during observational period for more than 1 week will be recognized as having a relapse of psychosis.
- Personal Social Performance (PSP) scores [ Time Frame: up to 2 years ]Patients will be rated by their attending psychiatrists with PSP scale to evaluate their functioning in 4 aspects of life, including socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviors as to give a summary score at baseline and annually
- quality of life (Euro-5D VAS) [ Time Frame: up to 2 years ]Patients report their quality of life using a 20-cm visual analogue at baseline and annually.
- severity of extrapyramidal symptoms [ Time Frame: up to 2 years ]Patient's severity of extrapyramidal symptoms will be rated by their psychiatrists using Simpson-Angus Scale, the Abnormal Involuntary Movement Scale, and the Barnes Akathisia Rating Scale at each visit.
- medication satisfaction questionnaire (MSQ) [ Time Frame: up to 2 years ]Patients will be asked to fill a self-rated 7-point Likert scale for medication satisfaction at baseline and annually.
- neurocognitive functioning [ Time Frame: up to 2 years ]Patients will be assessed with the module for schizophrenia of the Cambridge Neuropsychological Test Automatic Battery (Cantab) at baseline and at the exit of the study.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248180
|Contact: Chen-Chung Liu, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Chen-Chung Liu, MD, PhD 886-2-23123456 ext 66130 email@example.com|
|Principal Investigator:||Chen-Chung Liu, MD, PhD||National Taiwan University Hospital|