Schizophrenia Cognition Scale Development

NCT02118571 | Completed

• 1 other identifier: P1533
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 4

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).

Conditions

Schizophrenia; Cognition Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  One time qualitative interivew within two weeks of screening

Secondary Outcomes (3)

• Assessment of Conceptual Model using Qualitative Interviews

  One time qualitative interivew

• Assess content validity and comprehension of developed PRO measure

  One time qualitative interivew

• Development and testing of a new patient reported outcome (PRO) measure

  Patients will be interviewed within 2 weeks of consent

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carelon Research: lead
• Boehringer Ingelheim: collaborator

Study Sites (4)

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Rutgers University Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

Richmond Behavior Associates

Staten Island, New York, 10312, United States

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens collected

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Study Officials

• Raymond C Rosen, PhD

  New England Research Institutes, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: April 21, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 12, 2025

Record last verified: 2016-09

Locations

US (4)