DTx Product Profile

SparkRx®

Product Highlight

Condition targeted:

Symptoms of depression in adolescents

How it works:

Delivers core components of cognitive behavioral therapy (CBT) through a patient’s mobile device.

Impact:

Adolescents who used SparkRx showed a clinically significant reduction in depression symptoms.

Product Overview

Medical condition:

Symptoms of depression in adolescents

Target patient population:

Patients aged 13-22 with symptoms of depression can use SparkRx as a self-paced program to help understand their depression symptoms and learn coping skills to manage symptoms.

What to expect:

Reduction in depressive symptoms for adolescent patients, between 13 to 22 years of age.

 

Note: for more information, please visit https://www.sparkrx.com/.

Clinical Overview

Indications for use:

SparkRx is a digital therapeutic intended to provide a neurobehavioral intervention (cognitive behavioral therapy – behavioral activation) in patients 13 to 22 years of age as adjunct treatment for symptoms of depression. SparkRx has not been cleared or approved by the U.S. Food and Drug Administration. During the COVID-19 public health emergency, SparkRx is being made available without a prescription under the FDA’s emergency guidance for digital health devices treating psychiatric disorders.

Outcomes:

Research demonstrated that SparkRx resulted in a clinically meaningful reduction in depression symptoms. 24% of participants showed a treatment response and 17% were in remission by the end of the intervention.

Directions:

The SparkRx program has 5 levels. Patients are encouraged to complete 1 level each week, but are given 7 weeks of program access. Throughout the program, they complete interactive exercises to help them better understand their depression. They also learn coping skills to manage their symptoms, including activity scheduling, mindfulness, and mood tracking, and they earn rewards along the way. At the end of the program, patients review what they’ve learned and make a plan for managing symptoms after SparkRx.

Visit sparkrx.com to read our full Instructions for Use.

Risks & warnings:

SparkRx has not been cleared or approved by the U.S. Food and Drug Administration. SparkRx is not for emergency use. SparkRx is not meant to be used as treatment without supervision of a health care provider. SparkRx is not meant to be a substitution for any treatment or medication. SparkRx does not address concerns of active suicidal ideation with intent. SparkRx is not intended for the prevention of suicide attempts or self-harm behaviors.

Place in therapy:

SparkRx® is intended as an adjunctive treatment.

Product Access

Product description:

SparkRx is a software program intended as a digital therapeutic for symptoms of depression in adolescents. It may be used on a mobile device or tablet.

Prescription status:

Currently, under the FDA’s Enforcement Policy, a prescription is not required.

Patient access:

Providers register to offer SparkRx at sparkrx.com and receive an access code they can give to patients. Patients will download SparkRx from the app store on their Apple/Android device and enter their provider’s access code and create an account.

Provider access:

The Limbix Provider Portal allows healthcare providers to check their patients’ progress as they use the SparkRx program. With access to the portal, providers can monitor their patients’ clinical outcomes and program engagement by viewing their patients’ weekly PHQ-8 assessment results and real-time metrics about their progress with the SparkRx program.

Coverage options:

SparkRx is currently being offered at no cost to patients, regardless of their insurance coverage.

Product availability:

SparkRx® is available in:  

Unique Features.

SparkRx is the first digital treatment for adolescent depression. More young people are being diagnosed with depression than ever before. SparkRx is a treatment option with room for all of them.

Clinical Trials

Note: for more research, please visit http://sparkrx.com/clinical-research-summary.

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