Clinical trial NCT05838625: Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia
Official title: A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics As an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants with Experiential Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Prescription digital therapeutic (PDT)
Software as a Medical Device (SaMD)
Smartphone app
Schizophrenia
Negative Symptoms
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2023-05-01
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Detailed description: The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.

Eligibility criteria: Inclusion Criteria:

A participant will be eligible for entry into the study if all of the following criteria are met:

1. Has a primary diagnosis of schizophrenia.
2. Is on a stable dose of antipsychotic medication(s).
3. Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).

Exclusion Criteria:

A participant will not be eligible for study entry if any of the following criteria are met:

1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
2. Meets DSM-5, for diagnoses not under investigation.
3. Has participated in a CT-155 clinical study.

Primary outcomes:
measure: Experiential negative symptoms
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Motivation and pleasure symptoms
timeFrame: Baseline to Week 8
measure: Expressive negative symptoms
timeFrame: Baseline to Weeks 8 and 16
measure: Positive symptoms
timeFrame: Baseline to Weeks 8 and 16
measure: Social functioning
timeFrame: Baseline to Weeks 8 and 16
measure: Self-reported defeatist beliefs
timeFrame: Baseline to Weeks 8 and 16
measure: Patient global impression of improvement
timeFrame: Weeks 8 and 16
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Investigational center
state: Arizona
city: Phoenix
country: United States
facility: Investigational center
state: Arizona
city: Anaheim
country: United States
facility: Investigational center
state: California
city: Culver City
country: United States
facility: Investigational center
state: California
city: Garden Grove
country: United States
facility: Investigational center
state: California
city: La Habra
country: United States
facility: Investigational center
state: California
city: Long Beach
country: United States
facility: Investigational center
state: California
city: Los Angeles
country: United States
facility: Investigational center
state: California
city: Newport Beach
country: United States
facility: Investigational center
state: California
city: Oceanside
country: United States
facility: Investigational center
state: California
city: Orange
country: United States
facility: Investigational center
state: California
city: San Bernardino
country: United States
facility: Investigational center
state: California
city: Torrance
country: United States
facility: Investigational center
state: California
city: Cromwell
country: United States
facility: Investigational center
state: Connecticut
city: Hartford
country: United States
facility: Investigational center
state: Connecticut
city: Hialeah
country: United States
facility: Investigational center
state: Florida
city: Largo
country: United States
facility: Investigational center
state: Florida
city: Miami Lakes
country: United States
facility: Investigational center
state: Florida
city: Miami
country: United States
facility: Investigational center
state: Florida
city: Orlando
country: United States
facility: Investigational center
state: Florida
city: West Palm Beach
country: United States
facility: Investigational center
state: Florida
city: Atlanta
country: United States
facility: Investigational center
state: Georgia
city: Augusta
country: United States
facility: Investigational center
state: Georgia
city: Chicago
country: United States
facility: Investigational center
state: Illinois
city: Springfield
country: United States
facility: Investigational center
state: Illinois
city: Warrenville
country: United States
facility: Investigational center
state: Illinois
city: Marrero
country: United States
facility: Investigational center
state: Louisiana
city: Baltimore
country: United States
facility: Investigational center
state: Maryland
city: Boston
country: United States
facility: Investigational center
state: Massachusetts
city: Flowood
country: United States
facility: Investigational center
state: Mississippi
city: St. Louis
country: United States
facility: Investigational center
state: Missouri
city: Omaha
country: United States
facility: Investigational center
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational center
state: Nevada
city: Marlton
country: United States
facility: Investigational center
state: New Jersey
city: Cedarhurst
country: United States
facility: Investigational center
state: New York
city: Glen Oaks
country: United States
facility: Investigational center
state: New York
city: New York
country: United States
facility: Click Therapeutics
state: New York
city: New York
country: United States
facility: Investigational center
state: New York
city: Rochester
country: United States
facility: Investigational center
state: New York
city: Charlotte
country: United States
facility: Investigational center
state: North Carolina
city: Beachwood
country: United States
facility: Investigational center
state: Ohio
city: Cincinatti
country: United States
facility: Investigational center
state: Ohio
city: Columbus
country: United States
facility: Investigational center
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational center
state: Oklahoma
city: State College
country: United States
facility: Investigational center
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational center
state: South Carolina
city: Austin
country: United States
facility: Investigational center
state: Texas
city: Forth Worth
country: United States
facility: Investigational center
state: Texas
city: Houston
country: United States
facility: Investigational center
state: Texas
city: Irving
country: United States
facility: Investigational center
state: Texas
city: Mesquite
country: United States
facility: Investigational center
state: Texas
city: Plano
country: United States
facility: Investigational center
state: Texas
city: Salt Lake City
country: United States
facility: Investigational center
state: Utah
city: St. George
country: United States
facility: Investigational center
state: Utah
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MD, PhD, FAAN
role: STUDY_DIRECTOR
References: