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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02118571
Other study ID # P1533
Secondary ID
Status Completed
Phase N/A
First received February 25, 2014
Last updated June 20, 2017
Start date November 2013
Est. completion date July 2016

Study information

Verified date September 2016
Source New England Research Institutes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Sheppard Pratt Health System Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Rutgers University Robert Wood Johnson Medical School Piscataway New Jersey
United States Richmond Behavior Associates Staten Island New York

Sponsors (2)

Lead Sponsor Collaborator
New England Research Institutes Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. One time qualitative interivew
Secondary 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. One time qualitative interivew
Secondary 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. Patients will be interviewed within 2 weeks of consent
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