TAILOR - an experimental study comparing discontinuation with maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or schizophrenia-like psychosis without psychotic symptoms

TAILOR - a randomized clinical trial: Tapered discontinuation versus maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or schizophreniform psychosis in remission of psychotic symptoms - TAILOR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000565-23-DK

Enrollment

250

Registered

2016-06-27

Start date

2017-03-03

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly diagnosed schizophrenia or schizophreniform psychosis in remission of psychotic symptoms MedDRA version: 20.0 Level: LLT Classification code 10038631 Term: Residual schizophrenia, in remission System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and o

Interventions

Pharmaceutical Form: INN or Proposed INN: AMISULPRIDE CAS Number: 71675-85-9 Pharmaceutical Form: INN or Proposed INN: ARIPIPRAZOLE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age of minimum 18 years - First treatment in the OPUS treatment center with the ICD 10 diagnosis F20 (except F20.6) or F22 confirmed with the diagnostic interview SCAN (Schedule for Clinical Assessment in Neuropsychiatry) - Minimum three months remission of psychotic symptoms (based on assemessment with SAPS-Schedule for Assessment of Positive Symptoms in Schizophrenia) and within the first 11 months of treatment in the OPUS center. - In treatment with antipsychotic medication (daily or depot) - Fluent in Danish - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Patients in forensic psychiatry - Treatment with clozapine - Pregnancy or breastfeeding - Previous admission to psychiatric hospital due to psychotic relapse while treated with antipsychotic medication or tapering of antipsychotic medication

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To investigate the frequency of subjects who are not in treatment with antipsychotic medication and has remission of psychotic symptoms in the discontinuation group compared with the maintenance therapy group measured at one and two year follow up.;Primary end point(s): Det primary end point is dichotomous: Remission of psychotic symptoms (meaning SAPS = 2) in minimum three months and no antipsychotic medication in minimum three months ; Secondary Objective: To investigate the folowwing in the discontinuation group compared with the discontinuation group at one, two and five year follow up 2. The frequency of psychotic relapse 3. The frequency of sideeffects of antipsychotic medication 4. Social functioning 5. Cognitive functioning 6. The frequency of clinical recovery 7. Alcohol and psychoactive substance use ;Timepoint(s) of evaluation of this end point: One, two and five years after inclusion	—

Measure

Time frame

Main Objective: 1. To investigate the frequency of subjects who are not in treatment with antipsychotic medication and has remission of psychotic symptoms in the discontinuation group compared with the maintenance therapy group measured at one and two year follow up.;Primary end point(s): Det primary end point is dichotomous: Remission of psychotic symptoms (meaning SAPS = 2) in minimum three months and no antipsychotic medication in minimum three months ; Secondary Objective: To investigate the folowwing in the discontinuation group compared with the discontinuation group at one, two and five year follow up 2. The frequency of psychotic relapse 3. The frequency of sideeffects of antipsychotic medication 4. Social functioning 5. Cognitive functioning 6. The frequency of clinical recovery 7. Alcohol and psychoactive substance use ;Timepoint(s) of evaluation of this end point: One, two and five years after inclusion

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: One, two and five years after inclusion; Secondary end point(s): 1. Remission of psychotic symptoms (SAPS = 2) in minimum three months and in treatment with maximum 0-1 haloperidol equivalents antipsychotic medication in any given day 2. Antipsychotic-dose (haloperidol-equivalent) 3. Sideeffects of antipsychotic medication 4. Negative symptoms measured with SANS 5. Social functioning measured with GSDS 6. Cognitive function measured with BACS 7. Client satisfaction measured with CSQ 8. Psychosocial functioning measured with PSP og GAF 9. Remission of psychotic og negative symptoms in minimum three months and functional remission i minimum three months. 10. Remission of psychotic og negative symptoms in minimum six months and functional remission i minimum six months. 11. Clinical recovery: Two years remission of both psychotic and negative symptoms and functional remission in two years and no admission to a psychiatric hospital 12. Use of psychoactive substanses or alcohol assessed with time line follow-back 13. Sexual functioning measured with CSFQ 14. Quality of life measured with WHO-5 and selfrated health 15. General self-efficacy measured with GSE 16. Service user support measured with INSPIRE 17. Safety measures of how discontinuation and maintenance therapy influences mortality, suicide, admission to pscyhiatric hospital, psychotic relapse, persistent or significant disability or incapacity, seriuos selfharm and psychoactive substance and alcohol use.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: One, two and five years after inclusion; Secondary end point(s): 1. Remission of psychotic symptoms (SAPS = 2) in minimum three months and in treatment with maximum 0-1 haloperidol equivalents antipsychotic medication in any given day 2. Antipsychotic-dose (haloperidol-equivalent) 3. Sideeffects of antipsychotic medication 4. Negative symptoms measured with SANS 5. Social functioning measured with GSDS 6. Cognitive function measured with BACS 7. Client satisfaction measured with CSQ 8. Psychosocial functioning measured with PSP og GAF 9. Remission of psychotic og negative symptoms in minimum three months and functional remission i minimum three months. 10. Remission of psychotic og negative symptoms in minimum six months and functional remission i minimum six months. 11. Clinical recovery: Two years remission of both psychotic and negative symptoms and functional remission in two years and no admission to a psychiatric hospital 12. Use of psychoactive substanses or alcohol assessed with time line follow-back 13. Sexual functioning measured with CSFQ 14. Quality of life measured with WHO-5 and selfrated health 15. General self-efficacy measured with GSE 16. Service user support measured with INSPIRE 17. Safety measures of how discontinuation and maintenance therapy influences mortality, suicide, admission to pscyhiatric hospital, psychotic relapse, persistent or significant disability or incapacity, seriuos selfharm and psychoactive substance and alcohol use.

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Countries

Denmark

Contacts

Public ContactMerete Nordentoft

Merete Nordentoft

Merete.Nordentoft@regionh.dk004538647453

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026