Clinical Trial Results:
Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response
Summary
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EudraCT number |
2010-023446-70 |
Trial protocol |
AT |
Global end of trial date |
01 Apr 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
07 May 2022
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First version publication date |
07 May 2022
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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 |
NCT01251471
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01251471 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Austrian Science Fund (FWF)
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Sponsor organisation address |
Sensengasse 1, Vienna, Austria, 1090
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Public contact |
Assoc.Prof. Priv.Doz. Dr. Lukas Pezawas, Medical University of Vienna, lukas.pezawas@meduniwien.ac.at
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Scientific contact |
Assoc.Prof. Priv.Doz. Dr. Lukas Pezawas, Medical University of Vienna, lukas.pezawas@meduniwien.ac.at
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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 |
01 Apr 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Apr 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to relate functional and structural MR parameters (e.g. local and system level BOLD signal, gray matter, structural connectivity, surface and parcellation measures) to drug response and remission.
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Protection of trial subjects |
1. Escitalopram is available in clinical routine and drug treatment within this study did not differ from clinical routine including safety measure
2. With regard to magnetic resonance imaging safety measures such as ear protection was provided.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Sep 2011
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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 |
Austria: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
22
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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) |
22
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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 |
Patients were recruited at the outpatient clinic of the Department of Psychiatry and Psychotherapy at the Medical University of Vienna or by online and bulletin board advertisements. | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
22 | ||||||
Number of subjects completed |
22 | ||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Patient arm | ||||||
Arm description |
1) MDD diagnosis according to DSM-IV (German Structured Clinical Interview, SCID-I) and absence of any other axis I disorder, (2) Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20 and ≤30, (3) age between 18 and 50 years, (4) right-handedness, and (5) willingness to provide informed consent and ability to be managed as outpatient. | ||||||
Arm type |
treatment arm | ||||||
Investigational medicinal product name |
Escitalopram
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Escitalopram dosing reflected clinical practice with a fixed dose of 10 mg and the option to increase to 20 mg after d28 until the end of study visit in case of nonresponse.
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Patient arm
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Reporting group description |
1) MDD diagnosis according to DSM-IV (German Structured Clinical Interview, SCID-I) and absence of any other axis I disorder, (2) Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20 and ≤30, (3) age between 18 and 50 years, (4) right-handedness, and (5) willingness to provide informed consent and ability to be managed as outpatient. |
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End point title |
Primary Measure [1] | ||||||
End point description |
The primary measure of drug response was defined as percent change between pretreatment (d0) and end-of-treatment (d56) MADRS scores: DR = (1- MADRSd56/MADRSd0)*100.
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End point type |
Primary
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End point timeframe |
8 weeks
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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: To detect time-sensitive neural activation that could mediate drug response, the interaction-term of drug response and scan session was calculated. The goal of the study was to determine neural markers of drug response and not the efficacy of escitalopram, which is already been studied in clinical trials. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events were clinically assessed at each visit.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
18.0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There have been non-serious adverse events in this rather small sample |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30718459 |