SchizophreniaSEECNCT03571685
Sustainable Early Episode Clinic Study (SEEC)
A study testing Sustainable Early Episode Clinic Model of Care in people with Schizophrenia and Schizoaffective Disorder, run by Janssen Scientific Affairs, LLC at 1 site in United States.
Trial summary
The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Sustainable Early Episode Clinic Model of Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to 20 Dec 2019
- Phase
- Interventional
- 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
- Participants must be at least 18 years or older
- Participants within 5 years of a clinical diagnosis of Schizophrenia or Schizoaffective disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for these disorders
- Participants must be able to speak, read, and understand English
- Participants must sign an informed consent form
- Caregivers must be 18 years or older Caregivers must also be willing to attend the multi-family psychoeducation group series (Phase I)
- Caregivers must be willing to participate in monthly family therapy and/or monthly phone contact with staff for the duration of the study
- Caregivers must sign informed consent form
Who cannot join
- Co-occurring developmental disabilities
- Receiving electroconvulsive therapy
- Primary substance use disorder
- On permanent conservatorship
- Unable to complete baseline assessments due to acuity of psychiatric symptoms
- Caregivers who refuse to participate in the psychoeducation series of Phase 1
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- Caregivers who refuse monthly family therapy/phone contact with staff will be excluded
- Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by treatment team
- Caregiver is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee or the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Outpatient Behavioral Health Clinic
San Diego, California, 92105
About this study
Official title: A Prospective, Open Label, Quasi-Experimental Study of Adult Patients With Schizophrenia or Schizoaffective Disorder Within Five Years of Diagnosis Who Will Receive SEEC Intervention
The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization Program, Intensive Outpatient Program, Crisis House stay).
Read the detailed description
Schizophrenia is a severe mental illness that is one of the leading causes of long-term disability in the world. Recognizing the need for improved early treatment for participants diagnosed with Schizophrenia or Schizoaffective Disorder, a model was created for a "sustainable early episode clinic, SEEC." The goal of the SEEC model is to provide early intense intervention in 3 phases, with an ongoing maintenance phase, enabled by technology, resulting in improved participant outcomes and reduced long-term economic and social burden of schizophrenia. This study will last for up to a 36-month period.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Sustainable Early Episode Clinic Model of Care
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainable Early Episode Clinic Model of CareBehavioural
The first 8 weeks is the education phase. Participants attend classes every week for up to 6 hours. From 9 weeks to 10 months participants attend classes for 5 hours every other week. Based on individual progress. Participants can move to the maintenance phase. This phase provides minimal intervention but ongoing support/evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Sustainable Early Episode Clinic Model of Care | Experimental | The model of care given in the sustainable early episode clinic study, provides early intense intervention, with an ongoing maintenance phase in an outpatient setting. Receives: Behavioral: Sustainable Early Episode Clinic Model of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Intensity Service Utilization Rate
The rate of high intensity service utilization that is count per unit of time for mental health services will be reported. It is evaluated as the number of psychiatric hospitalizations, behavioral health emergency department visits, and number of times referred to a partial hospitalization program (PHP), intensive outpatient program (IOP), or Crisis Unit.
Measured: Baseline up to 36 months
Secondary outcomes (6)
Overall Healthcare Utilization Rate
Overall healthcare utilization rate that is count per unit of time of the healthcare resources which were utilized by the participants over over the time will be reported.
Measured: Baseline up to 36 months
Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale
The CRDPSS is an 8 item measure that assesses the severity of mental health symptoms that are important across psychotic disorders including:
Delusions, hallucinations, disorganized speech, abnormal psycho-motor behavior, negative symptoms, impaired cognition, depression and mania. Each item on the measure is rated on a 5 point scale with a symptom specific definition of each rating level: 0 = none, 1= equivocal, 2= present but mild, 3= present and moderate, 4= present and severe. Total Score is taken as summation. High score indicates worsening of symptoms.
Measured: Baseline up to 36 months
Change from Baseline in Clinical Global Impressions Scale (CGI-S)
The CGI-S measures illness severity and is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill participants).
Measured: Baseline up to 36 months
Change from Baseline in Personal and Social Performance (PSP) Scale
The PSP has 4 domains of functioning considered in this scale: (a) Socially useful activities including work and study, (b) Personal \& Social Relationships, (c) Self Care (d) Disturbing and aggressive behaviors. All rated from absent, mild, manifest, marked, severe and very severe. Scores of 1-30 reflect functioning so poor that the participant requires intensive support of supervision. 31-70 varying degree of difficulties 71-100 reflect only mild difficulties.
Measured: Baseline up to 36 months
Change from Baseline in Perceived Family Burden Scale (PFBS)
The purpose of the PFBS scale is to measure the burden of schizophrenia on the family of a participant. It is a 24-item questionnaire rated on a 5 point Likert type scale: 0 = the behavior isn't present and doesn't bother the relative, 1 = the behavior is present and doesn't bother the relative, 2 = the behavior is present and bothers the relative "a little", 3 = the behavior is present and bothers the relative "considerably", 4 = the behavior is present and bothers the relative "a great deal". High score indicates worsening of burden.
Measured: Baseline up to 36 months
Heinrichs-Carpenter Quality of Life Scale (QLS)
The QLS is used to evaluate defect symptoms and impaired functioning in non-hospitalized schizophrenic participants. It is a 21-item scale providing information on symptoms and functioning in the preceding 4 weeks. Each item is rated on 7 point scale. A sub scale score is being used in 4 sections ranging from 0-56. Low score represents worse functioning. Then a total score is taken by adding the 4 sections. Range of possible scores, 0-126. Lower sub scale scores and total scores indicates lower quality of life.
Measured: Baseline up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start31 Jan 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, quasi-experimental study of adult patients with Schizophrenia or Schizoaffective Disorder within five years of diagnosis who are receiving SEEC intervention in phases. Approximately 50 patients will be enrolled in the study. Caregivers who would like to participate will also be included. Patients will be followed prospectively over the study period up to 36 months.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571685
- Sponsor's protocol ID
- 2017-08A
- Acronym
- SEEC
- Status last verified
- Apr 2025
- First submitted
- 1 Mar 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Quasi-Experimental Study of Adult Patients With Schizophrenia or Schizoaffective Disorder Within Five Years of Diagnosis Who Will Receive SEEC Intervention
- ClinicalTrials.gov ID
- NCT03571685
- Acronym / sponsor ID
- SEEC / 2017-08A
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization Program, Intensive Outpatient Program, Crisis House stay).
Detailed description
Schizophrenia is a severe mental illness that is one of the leading causes of long-term disability in the world. Recognizing the need for improved early treatment for participants diagnosed with Schizophrenia or Schizoaffective Disorder, a model was created for a "sustainable early episode clinic, SEEC." The goal of the SEEC model is to provide early intense intervention in 3 phases, with an ongoing maintenance phase, enabled by technology, resulting in improved participant outcomes and reduced long-term economic and social burden of schizophrenia. This study will last for up to a 36-month period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, quasi-experimental study of adult patients with Schizophrenia or Schizoaffective Disorder within five years of diagnosis who are receiving SEEC intervention in phases. Approximately 50 patients will be enrolled in the study. Caregivers who would like to participate will also be included. Patients will be followed prospectively over the study period up to 36 months.
| Arm | Type | Receives |
|---|---|---|
| Sustainable Early Episode Clinic Model of Care | Experimental | Behavioral: Sustainable Early Episode Clinic Model of CareThe model of care given in the sustainable early episode clinic study, provides early intense intervention, with an ongoing maintenance phase in an outpatient setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be at least 18 years or older
- Participants within 5 years of a clinical diagnosis of Schizophrenia or Schizoaffective disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for these disorders
- Participants must be able to speak, read, and understand English
- Participants must sign an informed consent form
- Caregivers must be 18 years or older Caregivers must also be willing to attend the multi-family psychoeducation group series (Phase I)
Key exclusion criteria (9 listed)
- Co-occurring developmental disabilities
- Receiving electroconvulsive therapy
- Primary substance use disorder
- On permanent conservatorship
- Unable to complete baseline assessments due to acuity of psychiatric symptoms
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 |
|---|---|---|
| Sustainable Early Episode Clinic Model of CareThe first 8 weeks is the education phase. Participants attend classes every week for up to 6 hours. From 9 weeks to 10 months participants attend classes for 5 hours every other week. Based on individual progress. Participants can move to the maintenance phase. This phase provides minimal intervention but ongoing support/evaluation. | Behavioural | Sustainable Early Episode Clinic Model of Care |
Primary outcome
High Intensity Service Utilization Rate
Time frame: Baseline up to 36 months
The rate of high intensity service utilization that is count per unit of time for mental health services will be reported. It is evaluated as the number of psychiatric hospitalizations, behavioral health emergency department visits, and number of times referred to a partial hospitalization program (PHP), intensive outpatient program (IOP), or Crisis Unit.
6 secondary outcomes
Overall Healthcare Utilization Rate
Time frame: Baseline up to 36 months
Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale
Time frame: Baseline up to 36 months
Change from Baseline in Clinical Global Impressions Scale (CGI-S)
Time frame: Baseline up to 36 months
Change from Baseline in Personal and Social Performance (PSP) Scale
Time frame: Baseline up to 36 months
Change from Baseline in Perceived Family Burden Scale (PFBS)
Time frame: Baseline up to 36 months
Heinrichs-Carpenter Quality of Life Scale (QLS)
Time frame: Baseline up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustainable Early Episode Clinic Model of Care in people with Schizophrenia and Schizoaffective Disorder, run by Janssen Scientific Affairs, LLC at 1 site 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 7 inclusion and 9 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
High Intensity Service Utilization Rate (time frame: Baseline up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.