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Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders

S

Shalvata Mental Health Center

Status

Unknown

Conditions

Schizophrenia Disorder
PTSD
Bipolar Disorder
MDD
Anxiety Disorder (Panic Disorder or GAD)

Treatments

Behavioral: Generalization pattern

Study type

Observational

Funder types

Other

Identifiers

NCT01501812
SHA-04-11

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

180 participants in 6 patient groups

Schizophrenia
Description:
Subjects who are suffering from Schizophrenia or Schizoaffective disorder acording to the DSM-IV-R criteria
Treatment:
Behavioral: Generalization pattern
Control
Description:
Healthy subjects without any mental ilness in axis I or II.
Treatment:
Behavioral: Generalization pattern
Bipolar
Description:
Subjects who are suffering from bipolar I or 2 disorder acording to the DSM-IV-R criteria
Treatment:
Behavioral: Generalization pattern
MDD
Description:
Subjects who are suffering from Major Depressive disorder acording to the DSM-IV-R criteria
Treatment:
Behavioral: Generalization pattern
Anxiety
Description:
Subjects who are suffering from Panic disorder or from Generalized Anxiety disorder acording to the DSM-IV-R criteria
Treatment:
Behavioral: Generalization pattern
PTSD
Description:
Subjects who are suffering from Post Traumatic Stress Disorder acording to the DSM-IV-R criteria
Treatment:
Behavioral: Generalization pattern

Trial contacts and locations

1

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Central trial contact

Shahak Yariv, MD

Data sourced from clinicaltrials.gov

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