Clinical Trial Results:
a phase IV, double-blind randomised placebo-controlled, parallel group multi-site trial of sertraline compared to placebo in patients presenting with depressive symptoms in primary care where treatment with SSRIs is uncertain.
What are the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit? PANDA RCT
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Summary
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EudraCT number |
2013-003440-22 |
Trial protocol |
GB |
Global end of trial date |
31 Dec 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Oct 2019
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First version publication date |
20 Oct 2019
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Other versions |
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Summary report(s) |
Results Results Supplementary Appendix |
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 |
13/0413
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Additional study identifiers
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ISRCTN number |
ISRCTN84544741 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University College London
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Sponsor organisation address |
Joint Research Office, UCL, Gower Street, , London , United Kingdom, WC1E 6BT
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Public contact |
Glyn Lewis, University College London, +44 0207 679 9253, glyn.lewis@ucl.ac.uk
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Scientific contact |
Glyn Lewis, University College London, +44 0207 679 9253, glyn.lewis@ucl.ac.uk
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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 |
30 Aug 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Dec 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2017
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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 |
- To investigate the severity and duration of the depressive symptoms that are associated with a clinically important response (compared to placebo) to sertraline in people with depression.
- To investigate quality of life, the economic cost and whether performances on emotional processing tasks are associated with response to treatment with sertraline.
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Protection of trial subjects |
People with depression have an increased risk of self-harm and suicide. We therefore had a Suicidal Ideation SOP in place and staff were trained to follow this procedure.
The role of the trial steering committee for this trial was to provide independent oversight of ethical and safety aspects of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 May 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
United Kingdom: 655
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Worldwide total number of subjects |
655
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EEA total number of subjects |
655
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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) |
616
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From 65 to 84 years |
39
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from primary care practices across the UK, in the areas surrounding our four trial sites: Bristol, London, Liverpool and York. Bristol recruited the first participant in January 2015, London in July 2015, Liverpool in December 2015 and York in January 2016 | |||||||||||||||
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Pre-assignment
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Screening details |
Eligible participants were those who: were between the ages of 18 to 74; had presented to primary care with depression or low mood during the past 2 years; had not received antidepressant or anti-anxiety medication in the 8 weeks prior to enrolment in the trial and there was clinical equipoise about the benefits of SSRI medication. | |||||||||||||||
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Period 1
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Period 1 title |
Overall trial period (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Assessor | |||||||||||||||
Blinding implementation details |
- Over encapsulation.
- Randomisation was conducted by PRIMENT CTU using a remote computer-generated code (Sealed Envelope, https://sealedenvelope.com/).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sertraline | |||||||||||||||
Arm description |
one × 50 mg encapsulated sertraline for 1 week followed by two × 50 mg encapsulated sertraline for up to 11 weeks and then for a 2-week tapering period. If participants have not responded to treatment after the 6-week follow-up assessment, the medication can be increased to three × 50 mg encapsulated sertraline or identical placebo in consultation with the PI (Principal Investigator) | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Sertraline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
one × 50 mg encapsulated sertraline for 1 week followed by two × 50 mg encapsulated sertraline for up to 11 weeks and then for a 2-week tapering period. If participants have not responded to treatment after the 6-week follow-up assessment, the medication can be increased to three × 50 mg encapsulated sertraline.
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Arm title
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Placebo | |||||||||||||||
Arm description |
Matching placebo | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
100mg
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sertraline
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Reporting group description |
one × 50 mg encapsulated sertraline for 1 week followed by two × 50 mg encapsulated sertraline for up to 11 weeks and then for a 2-week tapering period. If participants have not responded to treatment after the 6-week follow-up assessment, the medication can be increased to three × 50 mg encapsulated sertraline or identical placebo in consultation with the PI (Principal Investigator) | ||
Reporting group title |
Placebo
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Reporting group description |
Matching placebo | ||
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End point title |
outcome at 6 weeks [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 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: Full details of the statistical analyses are detailed in the attached report. |
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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 |
baseline for the final to 12 weeks follow-up
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Adverse event reporting additional description |
Adverse events were recorded by a structured assessment in the 2, 6 and 12 week follow-up assessments. As this trial was a trial of a licensed medication with a well-established safety profile that is used within its licensed indication, AEs were not recorded from those AEs of special interest included in the follow up assessments.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
20.0
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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: See attached report for full details of all Adverse Events. |
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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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27 Apr 2015 |
In response to the NIHR stakeholder review, we further developed the analysis plan and the final version was sited in the section number 14.6, page 46 of the protocol. Amendments to the trial protocol have been made in line with agreed analysis plan. |
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16 Nov 2015 |
Following poor recruitment from practice mailouts and after consultations with PPI we changed the recruitment procedure to allow an additional telephone call to those who failed to respond to initial mailout |
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21 Mar 2016 |
Due to a release of SmPC v7 that mentioned an increased QT interval associated with Sertraline and after discussions with our Sponsor we amended the protocol |
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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 | |||
