Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 3313 for:    schizophrenia

Schizophrenia Cognition Scale Development (CIAS PRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118571
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
New England Research Institutes

Brief 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).

Condition or disease
Schizophrenia Cognition Disorders

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Schizophrenia Cognition Scale Development: Item Development and Psychometric Validation of a Novel Patient Reported Outcome (PRO) Measure for Research and Clinical Application
Study Start Date : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assessment of Conceptual Model using Qualitative Interviews [ Time Frame: One time qualitative interivew ]
    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.

  2. Assess content validity and comprehension of developed PRO measure [ Time Frame: One time qualitative interivew ]
    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.

  3. Development and testing of a new patient reported outcome (PRO) measure [ Time Frame: Patients will be interviewed within 2 weeks of consent ]
    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.


Biospecimen Retention:   None Retained
No biospecimens collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications
Criteria

Inclusion Criteria:

  1. 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)
    • 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)
  2. Male or female patients age 18 to 55 years
  3. Exhibits reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures.
  4. Able to provide informed consent

Exclusion Criteria:

  1. Patient currently treated with more than two antipsychotic medications
  2. 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
  3. 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)
  4. Non-psychiatric disorders of the central nervous system (including but not limited to any kind of seizures, stroke, or traumatic brain injury)
  5. Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this study
  6. In the 6 months prior, having met the criteria for dependence or abuse according to the DSM V in the opinion of the investigator.
  7. Participation in another trial with an investigational drug or procedure within 30 days prior to screening or previous participation in any BI 409306 study
  8. Unable to speak or read in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118571


Locations
Layout table for location information
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21285
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
Rutgers University Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
United States, New York
Richmond Behavior Associates
Staten Island, New York, United States, 10312
Sponsors and Collaborators
New England Research Institutes
Boehringer Ingelheim
Investigators
Layout table for investigator information
Principal Investigator: Raymond C Rosen, PhD New England Research Institutes, Inc.

Layout table for additonal information
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02118571     History of Changes
Other Study ID Numbers: P1533
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Cognition Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders