Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01501812
First received: December 27, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

Learning includes the ability to generalize to new situations and respond to similar, yet not identical stimuli. In previous work, focused on stimulus generalization in healthy volunteers, tones that were negatively reinforced induce wider generalization curves than tones that were positively reinforced, and these in turn induce wider curves than neutral memory (Schechtman et al, 2010).

The current study aimed to evaluate those patterns in different clinical disorders (including Schizophrenia, Bipolar disorder, MDD, Anxiety disorders (Panic and GAD) and PTSD, and healthy subjects that would be used as a control), with consideration whether those patterns are unique to any specific disorder or state.

The generalization patterns evaluation would conduct twice though enable to compare the stability of those patterns during the course of the illness (i.e during remission compared to acute state).

The basic paradigm based on conditioning of a tone (sound) with unpleasant noise, and extinction of that conditioning afterword. During the 60 minutes of evaluation, the capability to discriminate between the original tone and similar but not identical tones, and the tendency to categorize similar tones as identical to the original tone. A neutral tone without conditioning will be used as reference. The clinical diagnosis will conduct by a senior psychiatrist, and the state would be evaluated using standard questionnaires


Condition Intervention
MDD
Bipolar Disorder
Schizophrenia Disorder
Anxiety Disorder (Panic Disorder or GAD)
PTSD
Behavioral: Generalization pattern

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders (Schizophrenia, Affective Spectrum and Anxiety Disorders) - an Open, Single Center, Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Generalization pattern differentiation [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Compare the generalization curve and the differentiation between positive, negative and neutral valency bias


Secondary Outcome Measures:
  • State or trait differentiation [ Time Frame: 4-24 weeks ] [ Designated as safety issue: No ]
    to find the stability of the outcome between the two visits, and whether there is correlation with clinical state and the generalization patterns


Estimated Enrollment: 180
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Schizophrenia
Subjects who are suffering from Schizophrenia or Schizoaffective disorder acording to the DSM-IV-R criteria
Behavioral: Generalization pattern
During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound ("metal scratch") will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones ("neutral" and "aversive") before and after the conditioning, and after extinction phase. The generalization will also be measured by the "generalization curve" that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new
Control
Healthy subjects without any mental ilness in axis I or II.
Behavioral: Generalization pattern
During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound ("metal scratch") will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones ("neutral" and "aversive") before and after the conditioning, and after extinction phase. The generalization will also be measured by the "generalization curve" that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new
Bipolar
Subjects who are suffering from bipolar I or 2 disorder acording to the DSM-IV-R criteria
Behavioral: Generalization pattern
During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound ("metal scratch") will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones ("neutral" and "aversive") before and after the conditioning, and after extinction phase. The generalization will also be measured by the "generalization curve" that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new
MDD
Subjects who are suffering from Major Depressive disorder acording to the DSM-IV-R criteria
Behavioral: Generalization pattern
During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound ("metal scratch") will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones ("neutral" and "aversive") before and after the conditioning, and after extinction phase. The generalization will also be measured by the "generalization curve" that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new
Anxiety
Subjects who are suffering from Panic disorder or from Generalized Anxiety disorder acording to the DSM-IV-R criteria
Behavioral: Generalization pattern
During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound ("metal scratch") will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones ("neutral" and "aversive") before and after the conditioning, and after extinction phase. The generalization will also be measured by the "generalization curve" that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new
PTSD
Subjects who are suffering from Post Traumatic Stress Disorder acording to the DSM-IV-R criteria
Behavioral: Generalization pattern
During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound ("metal scratch") will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones ("neutral" and "aversive") before and after the conditioning, and after extinction phase. The generalization will also be measured by the "generalization curve" that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects with severe mental disorder in axis one (i.e Schizophrenia, Bipolar, MDD, Anxiety disorder including Panic or Generalized Disorders, PTSD)and healthy subjects that will be used as control- Thirty subjects at each of the groups.

Criteria

Inclusion Criteria:

  • Men and women 20-65 years of age.
  • Primary DSM-IV diagnosis of Schizophrenia, Schizoaffective, Bipolar (1 or 2) , Major depressive Disorder , Generalized anxiety disorder, panic disorder, post traumatic stress disorder based on SCID and confirmed by a senior psychiatrist, Or subjects without axis I or II diagnosis (control group).
  • Capable and willing to provide informed consent. In any case when there is doubt about the patients' capacity to sign an informed consent, an independent doctor will assess the patient capacities to make treatment decisions with the clinical tool MacCAT-T.
  • Able to adhere to the evaluation schedule.
  • Able to read, hear, write and speak Hebrew.
  • Has signed a written informed consent to participate in the study.

Exclusion Criteria:

  • Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia, anxiety disorder or affective disorder, including alcohol and drug dependence.
  • Subjects with significant cognitive impairment including dementia, history of head injury, mental retardation, or any other cause to "organic" cognitive impairment.
  • Current suicidal ideation or history of a suicide attempt in the past six month
  • Subjects who were under compulsory hospitalization.
  • Subjects with any other dominant axis I or II diagnosis mainly anxiety disorders, which might interfere with the evaluation of the above disorders.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501812

Contacts
Contact: Shahak Yariv, MD 972-54-9876823 dr.shahakyariv@gmail.com

Locations
Israel
Shalvat Mental Health Center Recruiting
Hod hasharon, Israel
Contact: Shahak Yariv, MD    972-54-9876823    dr.shahakyariv@gmail.com   
Principal Investigator: Shahak Yariv, MD         
Sponsors and Collaborators
Shalvata Mental Health Center
Weizmann Institute of Science
Investigators
Principal Investigator: Shahak Yariv, MD Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01501812     History of Changes
Other Study ID Numbers: SHA-04-11
Study First Received: December 27, 2011
Last Updated: December 27, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Bipolar Disorder
Panic Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 31, 2014