SchizophreniaPhase 2NCT04158687

A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia

A Phase 2 study testing CTP-692 in people with Schizophrenia, run by Concert Pharmaceuticals at 26 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

The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Schizophrenia
What is being tested?: CTP-692
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 326 participants
Where: 26 sitesUnited States
Study dates: 26 Nov 2019to 22 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
Patients currently treated with one antipsychotic medication

Who cannot join

Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
Patients currently taking clozapine
History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
Patients with history of renal disease or those taking medications to treat renal disease

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Donald J. Garcia Jr., MD, PA
Austin, Texas, 78737
Community Clinical Research, Inc.
Austin, Texas, 78754
Hassman Research Institute
Berlin, New Jersey, 08009
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Synexus Clinical Research US, Inc.
Cerritos, California, 90703
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407
Uptown Research Institute, LLC
Chicago, Illinois, 60640
ProScience Research Group
Culver City, California, 90230
InSite Clinical Research, LLC
DeSoto, Texas, 75115
CBH Health, LLC
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
Synexus Clinical Research US, Inc.
Jamaica, New York, 11432
Altea Research Institute
Las Vegas, Nevada, 89102
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Synergy San Diego
Lemon Grove, California, 91945
Pillar Clinical Research, LLC
Lincolnwood, Illinois, 60712
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
Hassman Research Institute
Marlton, New Jersey, 08053
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161
Pacific Research Partners, LLC
Oakland, California, 94607
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
Arch Clinical Trials, LLC
St Louis, Missouri, 63118
Collaborative Neuroscience Network, LLC
Torrance, California, 90502

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adult Patients With Schizophrenia

Conditions: Schizophrenia
Being tested: CTP-692, Placebo
Medical subject headings: Schizophrenia

What participants receive

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

CTP-692Drug
Administered as powder for oral solution.
PlaceboDrug
Administered as powder for oral solution.

Study groups in NCT04158687
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks. Receives: Drug: Placebo
CTP-692 1 gram QD	Experimental	Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks. Receives: Drug: CTP-692
CTP-692 2 grams QD	Experimental	Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks. Receives: Drug: CTP-692
CTP-692 4 grams QD	Experimental	Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks. Receives: Drug: CTP-692

What is being measured

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

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
PANSS measures symptom severity in participants with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item is rated with 1 to 7 points. The PANSS is scored by summation of ratings across items such that the score ranges are 7 to 49 for each of the Positive and Negative Scales and 16 to 112 for the General Psychopathology Scale. The PANSS total score is a sum of scores from all the 30 items and the scores range from 30 to 210, where a higher score represents more severe symptoms, and lower scores represent a better quality of life in participants with schizophrenia. A negative change from baseline indicates low severity of symptoms.
Measured: Baseline, Week 12

Secondary outcomes (2)

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
The CGI-S rating scale is a commonly used measure of symptom severity and treatment response. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment and the score ranges from 1 to 7: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. A higher score represents more severe symptoms. A negative change from baseline indicates low severity of symptoms.
Measured: Baseline, Week 12
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12
PSP scale is a measure of the personal and social functioning of participants with psychiatric disorders within four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Each domain was assessed on a 6-point scale: 1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe. The final global score is defined according to a summary instruction table converting four domain scores into a single, overall rating from 1 to 100: 71 to 100 represent mild degree of difficulty; 31 to 70 represent varying degrees of disability, and 1 to 30 represent functioning so poorly as to require intensive supervision. Higher scores represent better personal and social function. A positive change from baseline indicates better personal and social function.
Measured: Baseline, Week 12

Timeline

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

26 Nov 201922 Dec 2020

First posted12 Nov 2019
Study start26 Nov 2019
Primary completion22 Dec 2020
Study completion22 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04158687
Sponsor's protocol ID: CP692.2001
Status last verified: Dec 2023
First submitted: 7 Nov 2019
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adult Patients With Schizophrenia
ClinicalTrials.gov ID: NCT04158687
Acronym / sponsor ID: CP692.2001
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: Concert PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Cognitive Research Corporation
Study start: 26 Nov 2019 (actual)
Primary completion: 22 Dec 2020 (actual)
Study completion: 22 Dec 2020 (actual)
First posted: 12 Nov 2019 (actual)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks.
CTP-692 1 gram QD	Experimental	Drug: CTP-692Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.
CTP-692 2 grams QD	Experimental	Drug: CTP-692Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.
CTP-692 4 grams QD	Experimental	Drug: CTP-692Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
Patients currently treated with one antipsychotic medication

Key exclusion criteria (5 listed)

Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
Patients currently taking clozapine
History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
Patients with history of renal disease or those taking medications to treat renal disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CTP-692Administered as powder for oral solution.	Drug	CTP-692 1 gram QD, CTP-692 2 grams QD, CTP-692 4 grams QD
PlaceboAdministered as powder for oral solution.	Drug	Placebo

Primary outcome

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Time frame: Baseline, Week 12
PANSS measures symptom severity in participants with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item is rated with 1 to 7 points. The PANSS is scored by summation of ratings across items such that the score ranges are 7 to 49 for each of the Positive and Negative Scales and 16 to 112 for the General Psychopathology Scale. The PANSS total score is a sum of scores from all the 30 items and the scores range from 30 to 210, where a higher score represents more severe symptoms, and lower scores represent a better quality of life in participants with schizophrenia. A negative change from baseline indicates low severity of symptoms.

2 secondary outcomes

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	81	64
CTP-692 1 Gram QD	81	54
CTP-692 2 Grams QD	85	65
CTP-692 4 Grams QD	79	66

Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 80	CTP-692 1 Gram QD n = 81	CTP-692 2 Grams QD n = 83	CTP-692 4 Grams QD n = 77
Baseline	82.1 (8.2)	81.2 (8.0)	81.6 (7.8)	82.9 (8.6)
Change From Baseline at Week 12	-14.1 (10.4)	-15.9 (10.3)	-12.2 (10.3)	-11.0 (10.6)

Placebo vs CTP-692 1 Gram QD: Least Square (LS) Mean Difference: -0.9 (95% CI -4.5 to 2.6), p = 0.6003, Mixed model repeated measures (MMRM)
Placebo vs CTP-692 2 Grams QD: LS Mean Difference: 1.5 (95% CI -2.0 to 5.0), p = 0.3920, MMRM
Placebo vs CTP-692 4 Grams QD: LS Mean Difference: 2.6 (95% CI -0.9 to 6.0), p = 0.1444, MMRM

Population analysed: Efficacy population included all participants who received the study medication and had at least one available post-baseline PANSS assessment. 'Number of participants analyzed' indicates the number of participants with data available for analysis at the specified timepoint.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: Screening up to the last follow-up visit (approximately 18 weeks); Adverse events: From the first dose of study medication up to the last follow-up visit (approximately 13 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 81 (0%)	3 of 81 (3.7%)	0 of 81
CTP-692 1 Gram QD	1 of 81 (1.2%)	5 of 81 (6.2%)	0 of 81
CTP-692 2 Grams QD	0 of 85 (0%)	6 of 85 (7.1%)	0 of 85
CTP-692 4 Grams QD	1 of 78 (1.3%)	7 of 78 (9%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CTP-692 in people with Schizophrenia, run by Concert Pharmaceuticals at 26 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 3 inclusion and 5 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 (time frame: Baseline, Week 12). 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 NCT04158687.

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 22 Dec 2023.