Pivotal clinical trial results

FDA authorization is supported by the Mirai study, a clinical trial that demonstrated
improvements in MDD symptoms.1,2

MDD=major depressive disorder.

In the Mirai clinical trial of patients with MDD, when added to an ADT, Rejoyn

Reduced symptoms without side effects1

A landmark clinical trial1

The Mirai clinical trial evaluated the effectiveness and safety of Rejoyn as an adjunct to ADT in patients with MDD.1

Rejoyn Logo

194 patients Received Rejoyn, which included

Cognitive-Emotional Training1

3 simplified phone screens showing a CET memory task with photos of people showing different emotions on their faces

Rejoyn is a 6-week treatment that consists of1:

  • Working memory tasks
  • Identification of emotions
  • CBT-based video lessons

Control

192 patients received a

Cognitive-Training Control1

3 simplified phone screens showing a memory task with shapes

The control, or Sham, had a similar design and was matched for time and attention1:

  • Working memory tasks
  • Identification of shapes
  • No CBT-based video lessons

ADT=antidepressant therapy; CBT=cognitive behavioral therapy.

Study design

The safety and effectiveness of Rejoyn were evaluated in a pivotal, multicenter, remote, double-blind, randomized, controlled trial in adults with MDD who were on ADT.1

3-WEEK SCREENINGAdults (ages 22-64) with MDD who reported inadequate response to ADT monotherapyTREATMENT ARM + ADT Rejoyn(=194)nCognitive-emotional training (Emotional Faces Memory Task) + CBT-based video lessons+CONTROL ARM + ADT Shamn(=192)Cognitive training (shapes memory task)+6-WEEK TREATMENT PERIODContinue ADTOption to access therapy lessonsContinue ADT4-WEEK EXTENSIONDAY 1(N=386)1:1 patient randomization
Adults (ages 22-64) with MDD who reported inadequate response to ADT monotherapy1:1 patient randomization(N=386)TREATMENT ARMn(=194) + ADTRejoynCognitive-emotional training (Emotional Faces Memory Task) + CBT-based video lessons+CONTROL ARMn(=192) + ADTShamCognitive training (shapes memory task)+Continue ADT 1Option to access therapy lessonsContinue ADT3-WEEK SCREENINGDAY 16-WEEK TREATMENT PERIOD4-WEEK EXTENSIONTREATMENT ARMn(=194) + ADTRejoyn¹Cognitive-emotional training (Emotional Faces Memory Task) + CBT-based video lessonsIn the treatment arm, patients were tasked with completing:Rejoyn¹3 COGNITIVE-EMOTIONAL TRAINING (CET) EXERCISES 
EVERY WEEK¹15 sets of a sequential -back working memory task known as the Emotional Faces Memory Taskn³The patients had to identify and remember a sequence of faces, each portraying a certain emotion, and determine whether the emotion on the current face was the same as the emotion positions priorn¹Exercises involved matching faces 20 times in each of the 15 sets, totaling 5400 face matches by the end of 6 weeks³3 BRIEF CBT-BASED VIDEO LESSONS EVERY WEEK¹Patients received reminders to encourage engagement and messaging to reinforce the lesson content.¹–CONTROL ARMn(=192) + ADTSham¹Cognitive training (shapes memory task) the Cognitive-Training arm, patients were tasked with completing:InControl¹3 COGNITIVE TRAINING EXERCISES EVERY WEEK¹15 sets of a sequential -back working memory task using shapesn1,3These working memory tasks were expected to have cognitive effect; no emotional effect was expected given the neutral stimuli1,4Exercises involved matching shapes 20 times in each of the 15 sets, totaling 5400 shape matches by the end of 6 weeks1,3NO CBT-BASED LESSONS¹Patients received reminders to encourage engagement.¹–

The primary efficacy endpoint was the mean change from baseline to Week 6 in the MADRS total score for Rejoyn vs the Cognitive-Training Control.1

MADRS=Montgomery-Asberg Depression Rating Scale.

Efficacy endpoints were assessed in mITT and ITT analysis sets1

ITT

All patients enrolled and randomized

Rejoyn (n=194)

Sham (n=192)

mITT

  • Defined as full analysis set (FAS) in protocol and used for the primary efficacy endpoint analysis
  • Patients with 1 session with either treatment
  • Assessments of MADRS total score at baseline
  • Assessments of MADRS total score at ≥1 post-baseline timepoint

Rejoyn (n=177)

Sham (n=177)

ITT=intention-to-treat; LS=least squares; mITT=modified intention-to-treat.

Rejoyn was evaluated using the following scales:

Reduced depression symptoms (MADRS)1,5

The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated measure of depression severity commonly used in clinical trials, ranging from 0 to 60.1,5

ITT: Mean MADRS score reduced from 28.4 at baseline to 19.1 at Week 6 in the Rejoyn group (n=194), compared with 28.5 to 21.3 in the Sham group (n=192).1,6

Change in MADRS Total Score From Baseline to Week 61,5,6

MADRS ITT
MADRS ITT

Reduced depression symptoms (MADRS)1,5

The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated measure of depression severity commonly used in clinical trials, ranging from 0 to 60.1,5

mITT: Mean MADRS score reduced from 28.5 at baseline to 19.2 at Week 6 in the Rejoyn group (n=176), compared with 28.4 to 21.0 in the Sham group (n=176).1,6

Primary endpoint: Change in MADRS Total Score From Baseline to Week 61,5,6

MADRS mITT
MADRS mITT

Meaningfully reduced depression severity from moderately severe to mild (PHQ-9)1,7†

ITT: Mean PHQ-9 score reduced from 15.4 at baseline to 8.4 at Week 6 in the Rejoyn group (n=194), compared with 15.2 to 10.1 in the Sham group (n=192).1,6

Change in PHQ-9 Score From Baseline to Week 61,6,7

PHG-9 ITT
PHG-9 ITT

Meaningfully reduced depression severity from moderately severe to mild (PHQ-9)1,7†

mITT: Mean PHQ-9 score reduced from 15.3 at baseline to 8.4 at Week 6 in the Rejoyn group (n=167), compared with 15.1 to 10.0 in the Sham group (n=164).1,6

Change in PHQ-9 Score From Baseline to Week 61,6,7

PHG-9 mITT
PHG-9 mITT

Meaningfully reduced depression severity from moderately ill to mildly ill (CGI-S)1,8†

ITT: Mean CGI-S score reduced from 4.3 at baseline to 3.2 at Week 6 in the Rejoyn group (n=194), compared with 4.3 to 3.5 in the Sham group (n=192).1,6

Change in CGI-S Score From Baseline to Week 61,6,8

CGI-S ITT
CGI-S ITT

Meaningfully reduced depression severity from moderately ill to mildly ill (CGI-S)1,8†

mITT: Mean CGI-S score reduced from 4.3 at baseline to 3.2 at Week 6 in the Rejoyn group (n=175), compared with 4.3 to 3.5 in the Sham group (n=175).1,6

Change in CGI-S Score From Baseline to Week 61,6,8

CGI-S mITT
CGI-S mITT

*Change from baseline represents LS mean change from statistical model.1

*Change from baseline represents LS mean change from statistical model.1

†Sham meaningfully reduced depression severity from moderately severe to moderate.1

PHQ-9=Patient Health Questionnaire 9.

*Change from baseline represents LS mean change from statistical model.1

†A change ≥1 is clinically meaningful.8

CGI-S=Clinical Global Impressions-Severity Scale.

The efficacy results for ITT and mITT were consistent across patient and clinician-rated scales.1

  • Full or partial response

    51.3%

    of patients using Rejoyn experienced a full or partial response at Week 6 vs 38.7% of patients using Sham1

    Full or partial response is defined as ≥30% MADRS reduction from baseline at Week 61

    ITT population. P=0.0191.

  • Remission

    18.2%

    of patients using Rejoyn experienced remission at Week 6 vs 13.0% of patients using Sham1

    Remission is defined as ≥50% MADRS reduction from baseline and MADRS ≤10 at Week 61

    ITT population. P=0.1934.

  • Rate of adherence

    88.1%

    of people using Rejoyn adhered to treatment in the clinical trial, defined as completing at least 12 of the 18 treatment sessions.1

  • Patient satisfaction

    76%

    of people using Rejoyn reported that they were “extremely satisfied” (37.1%) or “satisfied” (38.9%) with the experience.1

  • Durability of effect

    During the month following the 6-week treatment, the effect of Rejoyn persisted with a trend favoring continued improvement.1

Improved MDD symptoms in patients with moderate or higher anxiety1

Rejoyn was shown to improve MDD symptoms in patients with moderate or higher anxiety symptoms at baseline (GAD-7 score of ≥10) compared to Sham (MADRS reduction: -9.01 points vs -5.39 points; P=0.0099).1

GAD-7=Generalized Anxiety Disorder-7.

Zero adverse events related to Rejoyn1

Rejoyn is an app, so it has a different adverse event profile than medications. In a clinical trial, no adverse events were assessed as related to Rejoyn.1

TEAEs1 Rejoyn
(n=187)		 Control
(n=186)
Upper respiratory tract infection 1.1%
(n=2)		 3.2%
(n=6)
Nasopharyngitis 1.1%
(n=2)		 2.7%
(n=5)
Headache 2.1%
(n=4)		 1.6%
(n=3)

During the treatment period, one subject in the Rejoyn group experienced worsening depressive symptoms (based on predefined protocol criteria). In the Rejoyn group, 3.21% (n=6) of subjects reported clinically important suicidality (based on predefined protocol criteria), compared to 4.84% (n=9) of subjects in the Sham group. During the extension period, 0.53% (n=1) of subjects in the Rejoyn group and 1.08% (n=2) of subjects in the Sham group had clinically important suicidality.1

TEAE=treatment-emergent adverse event.

Join us for a peer-led virtual program

Learn more about Rejoyn and MDD symptom management during a peer-led virtual program. By attending the program, you will:

  • Gain insight into the need for innovative treatments that may address neural dysfunction in MDD
  • Discover the unique mechanism of action of Rejoyn2
  • Explore the clinical evidence supporting the efficacy and safety of Rejoyn1
  • Learn how to prescribe Rejoyn and augment your patient's MDD treatment without additional side effects1
REGISTER

Talk to an Otsuka Medical Science Liaison (MSL)

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Thiago Queiroz

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Scott Schepers

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Pooja Raghani

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Mark Thomas

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MSL

Talk to an Otsuka Medical Science Liaison (MSL)

An MSL can provide additional information and answer questions you may have about Rejoyn.

REQUEST A CALL

Maria Perez

MSL
MSL

Talk to an Otsuka Medical Science Liaison (MSL)

An MSL can provide additional information and answer questions you may have about Rejoyn.

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Anna Smitherman

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Woman sitting on a chair looking at her smartphone using the Rejoyn app
Woman sitting on a chair looking at her smartphone using the Rejoyn app

Is Rejoyn right for your patients?

Learn more about Rejoyn and if it could be a good fit for your patients.

LOOK INSIDE REJOYN

INDICATION: Rejoyn is a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

SAFETY INFORMATION: Rejoyn is not intended to be used as a standalone therapy or a substitute for medication. Patients should continue their current treatment as directed.

Rejoyn does not monitor the patient's symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber. Patients should be clearly instructed that if they believe their depression is worsening or if they have feelings or thoughts of harming themselves or others, to contact a healthcare professional, dial 911 or go to the nearest emergency room immediately.

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