Clinical data: Rejoyn helped reduce symptoms of MDD

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

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

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 6^1,5,6

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 6^1,5,6

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 6^1,6,7

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 6^1,6,7

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 6^1,6,8

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 6^1,6,8

^*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.