SchizophreniaCIAS PRONCT02118571
Schizophrenia Cognition Scale Development
An observational study of Schizophrenia and Cognition Disorders, run by Carelon Research at 4 sites in United States.
Trial summary
The objective of this protocol is to develop items for a patient-reported outcome (PRO) measure to assess the patient's perspective and subjective experience of cognitive impairment associated with schizophrenia (CIAS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Cognition Disorders
- How many people
- 102 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2013to Jul 2016
- Phase
- Observational
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications
Who may be able to join
- Patients with established diagnoses of schizophrenia (confirmed by the Structured Clinical Interview for DSM-IV [full version or Clinical Trial version] either performed as part of the study screening process or as documented in the medical record within 2 years prior to the study) with the following clinical features:
- a)Clinically stable and in the residual (non-acute) phase of their illness for at least 8 weeks
- b)Maintained on current antipsychotic and concomitant psychotropic medications for at least 6 weeks and on current dose for at least 2 weeks
- c)Have no more than a ''moderate'' severity rating on hallucinations and delusions (e.g. Positive and Negative Syndrome Scale [PANSS] item scores < 5
- d)Have no more than a ''moderate'' severity rating on positive formal thought disorder (e.g. Positive and Negative Syndrome Scale [PANSS] conceptual disorganization item score < 5)
- e)Have no more than a ''moderate'' severity rating on negative symptoms (e.g., Positive and Negative Syndrome Scale-negative syndrome total score < 21)
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- f) Have no more than a minimal level of depressive symptoms (e.g. Calgary Depression Scale total score < 10); or, for eligibility for a waiting list, have a moderate level of depressive symptoms (e.g., Calgary Depression Scale total score between 10 and 15)
- Male or female patients age 18 to 55 years
- Exhibits reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures.
- Able to provide informed consent
Who cannot join
- Patient currently treated with more than two antipsychotic medications
- Patient's cognitive impairment severity compromises the ability of the participant to participate meaningfully in a semi-structured interview, in the clinical judgment of the investigator
- Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- Non-psychiatric disorders of the central nervous system (including but not limited to any kind of seizures, stroke, or traumatic brain injury)
- Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this study
- In the 6 months prior, having met the criteria for dependence or abuse according to the DSM V in the opinion of the investigator.
- Participation in another trial with an investigational drug or procedure within 30 days prior to screening or previous participation in any BI 409306 study
- Unable to speak or read in English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sheppard Pratt Health System
Baltimore, Maryland, 21285
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rutgers University Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
Richmond Behavior Associates
Staten Island, New York, 10312
About this study
Official title: Schizophrenia Cognition Scale Development: Item Development and Psychometric Validation of a Novel Patient Reported Outcome (PRO) Measure for Research and Clinical Application
The objective of this protocol is to develop items for a patient-reported outcome (PRO) measure to assess the patient's perspective and subjective experience of cognitive impairment associated with schizophrenia (CIAS).
Read the detailed description
Cognitive impairment associated with schizophrenia (CIAS) has been shown to be the strongest predictor of functional impairment among people with schizophrenia because it is associated with poor response to psychosocial interventions, employment status, and social functioning. Because the subjective experience of CIAS is likely to be associated with patient burden, distress, and motivation for treatment, it is important that this experience be assessed in a reliable and valid manner and from the perspective of the patient's self report. No existing instrument to assess CIAS has been developed with patient input directly about their qualitative experience of impaired cognition during the item generation stage, in accordance with FDA guidance for patient-reported outcome (PRO) measures.
- Conditions
- Schizophrenia, Cognition Disorders
- Medical subject headings
- Schizophrenia, Cognition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Impairment Associated with Schizophrenia
Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.
Measured: One time qualitative interivew within two weeks of screening
Secondary outcomes (3)
Assessment of Conceptual Model using Qualitative Interviews
Semi structured qualitative interviews will be conducted with adult subjects with schizophrenia. The results of the interviews will be analyzed using standard methods of inductive, iterative analysis. The results will serve as the basis for generating draft items for the PRO measure.
Measured: One time qualitative interivew
Assess content validity and comprehension of developed PRO measure
Following generation of draft PRO items, an independent series of qualitative interviews will take place in order to evaluate the draft items and ensure they accurately reflect the patient experience of cognitive impairment associated with schizophrenia.
Measured: One time qualitative interivew
Development and testing of a new patient reported outcome (PRO) measure
Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.
Measured: Patients will be interviewed within 2 weeks of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionJul 2016
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Raymond C Rosen, PhD, Principal investigator, New England Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118571
- Sponsor's protocol ID
- P1533
- Acronym
- CIAS PRO
- Status last verified
- Sep 2016
- First submitted
- 25 Feb 2014
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia Cognition Scale Development: Item Development and Psychometric Validation of a Novel Patient Reported Outcome (PRO) Measure for Research and Clinical Application
- ClinicalTrials.gov ID
- NCT02118571
- Acronym / sponsor ID
- CIAS PRO / P1533
- Conditions
- Schizophrenia, Cognition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Nov 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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 objective of this protocol is to develop items for a patient-reported outcome (PRO) measure to assess the patient's perspective and subjective experience of cognitive impairment associated with schizophrenia (CIAS).
Detailed description
Cognitive impairment associated with schizophrenia (CIAS) has been shown to be the strongest predictor of functional impairment among people with schizophrenia because it is associated with poor response to psychosocial interventions, employment status, and social functioning. Because the subjective experience of CIAS is likely to be associated with patient burden, distress, and motivation for treatment, it is important that this experience be assessed in a reliable and valid manner and from the perspective of the patient's self report. No existing instrument to assess CIAS has been developed with patient input directly about their qualitative experience of impaired cognition during the item generation stage, in accordance with FDA guidance for patient-reported outcome (PRO) measures.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications
Key inclusion criteria (10 listed)
- Patients with established diagnoses of schizophrenia (confirmed by the Structured Clinical Interview for DSM-IV [full version or Clinical Trial version] either performed as part of the study screening process or as documented in the medical record within 2 years prior to the study) with the following clinical features:
- Male or female patients age 18 to 55 years
- Exhibits reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures.
- Able to provide informed consent
Key exclusion criteria (8 listed)
- Patient currently treated with more than two antipsychotic medications
- Patient's cognitive impairment severity compromises the ability of the participant to participate meaningfully in a semi-structured interview, in the clinical judgment of the investigator
- Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- Non-psychiatric disorders of the central nervous system (including but not limited to any kind of seizures, stroke, or traumatic brain injury)
- Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Impairment Associated with Schizophrenia
Time frame: One time qualitative interivew within two weeks of screening
Using qualitative interview methods, adult subjects with a diagnosis of schizophrenia will provide self reported experience of cognitive impairments associated with schizophrenia. Domains and content will be identified and explored with the subjects and used to develop the PRO measure.
3 secondary outcomes
Assessment of Conceptual Model using Qualitative Interviews
Time frame: One time qualitative interivew
Assess content validity and comprehension of developed PRO measure
Time frame: One time qualitative interivew
Development and testing of a new patient reported outcome (PRO) measure
Time frame: Patients will be interviewed within 2 weeks of consent
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 12 Feb 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.
Raymond C Rosen, PhD principal investigator
New England Research Institutes, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Cognition Disorders, run by Carelon Research at 4 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 10 inclusion and 8 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Cognitive Impairment Associated with Schizophrenia (time frame: One time qualitative interivew within two weeks of screening). 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 12 Feb 2025.