Clinical Trial Results:
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
Summary
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EudraCT number |
2016-000565-23 |
Trial protocol |
DK |
Global end of trial date |
19 Oct 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
28 May 2021
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First version publication date |
28 May 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2016-867
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Copenhagen Research Center for Mental Health, CORE
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Sponsor organisation address |
Gentoftehospitalsvej 15, 4. sal, Hellerup, Denmark, 2900
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Public contact |
Merete Nordentoft, Copenhagen Research Center for Mental Health, CORE, Merete.Nordentoft@regionh.dk
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Scientific contact |
Merete Nordentoft, Copenhagen Research Center for Mental Health, CORE, Merete.Nordentoft@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Dec 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Oct 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Oct 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
Safety was ensured by regular visits in the early intervention service, monthly telephonic assessment of psychotic symptoms and monitoring by Good Clinical Practice (GCP) including reports of adverse events/reactions and serious adverse events/reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 May 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 29
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Worldwide total number of subjects |
29
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EEA total number of subjects |
29
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
29
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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Screening details |
Evaluated by medical doctors | ||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind [1] | ||||||||||||||||||
Roles blinded |
Data analyst, Assessor [2] | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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intervention | ||||||||||||||||||
Arm description |
Patients within this arm received tapered discontinuation of their antipsychotic medication | ||||||||||||||||||
Arm type |
Tapered discontinuation | ||||||||||||||||||
Investigational medicinal product name |
Any antipsychotic medication approved for schizophrenia or schizophreniform psychosis
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection, Oral drops, Tablet
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Routes of administration |
Intramuscular use, Oral use
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Dosage and administration details |
Study participants were tapered off their antipsychotic medication which they already took before entering the trial
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Arm title
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control | ||||||||||||||||||
Arm description |
Study participant received usual maintenance treatment with antipsychotic medication | ||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Notes [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial. Justification: assessors and researchers were blinded to the randomization. But neither study participant nor clinicians were blinded. [2] - The roles blinded appear inconsistent with a simple blinded trial. Justification: assessors and researchers were blinded to the randomization. But neither study participant nor clinicians were blinded. |
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Baseline characteristics reporting groups
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Reporting group title |
intervention
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Reporting group description |
Patients within this arm received tapered discontinuation of their antipsychotic medication | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
control
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Reporting group description |
Study participant received usual maintenance treatment with antipsychotic medication | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
intervention
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Reporting group description |
Patients within this arm received tapered discontinuation of their antipsychotic medication | ||
Reporting group title |
control
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Reporting group description |
Study participant received usual maintenance treatment with antipsychotic medication |
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End point title |
Remission of psychotic symptoms (meaning SAPS ≤ 2) in minimum three months and no antipsychotic medication in minimum three months [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
7th of May 2018 to 1st of June 2020
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were made due to an insufficient number of included participants and analysis made would potentially be misleading |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
3rd of July to 6th of January 2020
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
intervention
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
control
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Mar 2018 |
Change of inclusion criteria from patients having received 11 months treatment in an OPUS team to having 12 months left of treatment |
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08 Mar 2019 |
The use of a mobile phone application was discarded, adjustment of expected number of included study participants, inclusion of one more trial site and deletion of five-year follow-up. |
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22 Jul 2020 |
Deletion of two-year follow-up |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |