Status:
UNKNOWN
Guided Dose Reduction of Antipsychotic in Patients With Psychosis in Remitted States
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Psychosis
Remission
Eligibility:
All Genders
18-50 years
Brief Summary
A 2-year prospective observational study comparing a group of patients in remitted states of psychosis undergoing guided antipsychotic dose reduction to a similar group of patients under maintenance a...
Detailed Description
Early intervention at the beginning of schizophrenia and related psychotic disorders can get better treatment response. Once symptoms subsided, the majority of patients wish to discontinue medications...
Eligibility Criteria
Inclusion
- A diagnosis of schizophrenia, schizophreniform disorder, psychosis NOS, based on the DSM-5 criteria
- With a Positive and Negative Syndrome Scale (PANSS), score \< 3 in all 3 positive symptoms (P1: delusion, P2: conceptual disorganization, P3: hallucination) and 2 general symptoms (G9: unusual thought, G5: mannerism and posturing) for at least 3 months
- With a PANSS score \< 4 in all 3 negative symptoms (N1: blunted affect, N4: social withdrawal, N6: lack of spontaneity/flow in conversation) for at least 3 months
- Currently receiving antipsychotic treatment at a fixed dose for at least 3 months, including long-acting injectable antipsychotic
- A second antipsychotic agent only used for a low-dose, as needed adjuvant purpose
- No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during past 3 months -
Exclusion
- A score of 5 or more on any of the 30 PANSS rating items at screening
- Admission to acute psychiatric unit during past 6 months
- A change in dose of current antipsychotic medication in recent 3 months
- Concomitant use of mood stabilizers, such as lithium, valproic acid or other anti-epileptic drugs
- Mental retardation known as IQ below 70 prior to the diagnosis of schizophrenia
- A history of pervasive mental disorder or bipolar disorder
- A medical condition with significant cognitive sequelae
- A history of substance dependence during past 6 months
- Currently in pregnancy or breastfeeding
Key Trial Info
Start Date :
July 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03248180
Start Date
July 24 2017
End Date
December 31 2020
Last Update
August 14 2017
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100