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SchizophreniaPhase 3CONVOKENCT05838625

Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia

A Phase 3 study testing CT-155 in people with Schizophrenia, run by Click Therapeutics, Inc. at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
CT-155
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
54 sitesUnited States
Study dates
31 Mar 2023to 23 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A participant will be eligible for entry into the study if all of the following criteria are met:
  • Has a primary diagnosis of schizophrenia.
  • Is on a stable dose of antipsychotic medication(s).
  • Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).

Who cannot join

  • A participant will not be eligible for study entry if any of the following criteria are met:
  • Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
  • Meets DSM-5, for diagnoses not under investigation.
  • Has participated in a CT-155 clinical study.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Investigational center

    Anaheim, California, 92805

  • Investigational center

    Atlanta, Georgia, 30338

  • Investigational center

    Augusta, Georgia, 30912

  • Investigational center

    Austin, Texas, 78752

  • Investigational center

    Baltimore, Maryland, 21204

  • Investigational center

    Beachwood, Ohio, 44122

  • Investigational center

    Boston, Massachusetts, 02131

  • Investigational center

    Cedarhurst, New York, 11516

  • Investigational center

    Chandler, Arizona, 85226

  • Investigational center

    Charleston, South Carolina, 29425

  • Investigational center

    Charlotte, North Carolina, 27608

  • Investigational center

    Chicago, Illinois, 60611

  • Investigational center

    Cincinnati, Ohio, 45267

  • Investigational center

    Columbus, Ohio, 43210

  • Investigational center

    Cromwell, Connecticut, 06416

  • Investigational center

    Culver City, California, 90230

  • Investigational center

    Flowood, Mississippi, 39232

  • Investigational center

    Fort Worth, Texas, 76104

  • Investigational center

    Garden Grove, California, 92845

  • Investigational center

    Glen Oaks, New York, 11004

  • Investigational center

    Hartford, Connecticut, 06116

  • Investigational center

    Hialeah, Florida, 33016

  • Investigational center

    Houston, Texas, 77030

  • Investigational center

    Irving, Texas, 75062

  • Investigational center

    La Habra, California, 90631

  • Investigational center

    Largo, Florida, 33777

  • Investigational center

    Las Vegas, Nevada, 89124

  • Investigational center

    Long Beach, California, 90807

  • Investigational center

    Los Angeles, California, 90025

  • Investigational center

    Marlton, New Jersey, 08054

  • Investigational center

    Marrero, Louisiana, 70072

  • Investigational center

    Mesquite, Texas, 75149

  • Investigational center

    Miami, Florida, 33156

  • Investigational center

    Miami Lakes, Florida, 33014

  • Click Therapeutics

    New York, New York, 10013

  • Investigational center

    New York, New York, 10027

  • Investigational center

    Newport Beach, California, 92660

  • Investigational center

    Oceanside, California, 92056

  • Investigational center

    Oklahoma City, Oklahoma, 73116

  • Investigational center

    Omaha, Nebraska, 68144

  • Investigational center

    Orange, California, 92868

  • Investigational center

    Orlando, Florida, 32803

  • Investigational center

    Phoenix, Arizona, 85012

  • Investigational center

    Plano, Texas, 75093

  • Investigational center

    Rochester, New York, 14623

  • Investigational center

    Salt Lake City, Utah, 84105

  • Investigational center

    San Bernardino, California, 92408

  • Investigational center

    Springfield, Illinois, 77030

  • Investigational center

    St Louis, Missouri, 63141

  • Investigational center

    St. George, Utah, 84770

  • Investigational center

    State College, Pennsylvania, 16801

  • Investigational center

    Torrance, California, 90504

  • Investigational center

    Warrenville, Illinois, 60555

  • Investigational center

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Schizophrenia
Being tested
CT-155, Digital Control
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-155Device

    A software-based mobile application intended as a prescription digital therapeutic.

  • Digital ControlDevice

    A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit

Study groups in NCT05838625
Study groupRoleWhat they receive
Ct-155ExperimentalA software-based mobile application intended as an investigational treatment adjunctive to standard of care in individuals with experiential negative symptoms of schizophrenia
Receives: Device: CT-155
Digital ControlExperimentalA software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit
Receives: Device: Digital Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Experiential negative symptoms

    Change from baseline to Week 16 in experiential negative symptoms, as assessed by Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)

    Measured: Baseline to Week 16

Secondary outcomes (6)

  1. Motivation and pleasure symptoms

    Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP

    Measured: Baseline to Week 8

  2. Expressive negative symptoms

    Change from baseline in expressive negative symptoms at Weeks 8 and 16, as assessed by the Clinical Assessment Interview for Negative Symptoms, Expressivity Scale (CAINS-EXP)

    Measured: Baseline to Weeks 8 and 16

  3. Positive symptoms

    Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)

    Measured: Baseline to Weeks 8 and 16

  4. Social functioning

    Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)

    Measured: Baseline to Weeks 8 and 16

  5. Self-reported defeatist beliefs

    Change from baseline in self-reported defeatist beliefs at Weeks 8 and 16, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitudes Scale (DAS)

    Measured: Baseline to Weeks 8 and 16

  6. Patient global impression of improvement

    Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16

    Measured: Weeks 8 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start31 Mar 2023
  3. Primary completion20 Jun 2025
  4. Study completion23 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05838625
Sponsor's protocol ID
CT-155-R-001
Acronym
CONVOKE
Status last verified
Jun 2026
First submitted
20 Apr 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Pratap A, Lakhan SE, Snipes C, Tang W, Besedina O, Dickerson F, Kahn RS, Lindenmayer JP, Winderbaum Fernandez J, Mattingly GW, Torous J, Strauss GP, Speier A, von der Goltz C, Dorner-Ciossek C. A Digital Therapeutic Intervention for Negative Symptoms of Schizophrenia: A Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2635753. doi: 10.1001/jamanetworkopen.2026.35753.

    PubMed 42789268

  • Lakhan SE, Dorner-Ciossek C, Besedina O, Dickerson F, Hastedt C, Isla R, Kahn RS, Lindenmayer JP, Mehta R, Snipes C, Speier A, Tang W, Willis B, Fernandez JW, von der Goltz C, Pratap A. Effectiveness, Engagement, and Safety of a Digital Therapeutic (CT-155/BI 3972080) for Treating Negative Symptoms in People With Schizophrenia: Protocol for the Phase 3 CONVOKE Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 7;14:e81293. doi: 10.2196/81293.

    PubMed 41057039

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-155 in people with Schizophrenia, run by Click Therapeutics, Inc. at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Experiential negative symptoms (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05838625, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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