Clinical trial NCT01501812: Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders
Official title: Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders (Schizophrenia, Affective Spectrum and Anxiety Disorders) - an Open, Single Center, Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MDD
Bipolar Disorder
Schizophrenia Disorder
Anxiety Disorder (Panic Disorder or GAD)
PTSD
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2011-12-29
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Generalization pattern differentiation
timeFrame: 60 minutes
Secondary outcomes:
measure: State or trait differentiation
timeFrame: 4-24 weeks
Other outcomes:
Locations:
city: Hod hasharon
country: Israel
facility: Shalvat Mental Health Center
Study officials:
affiliation: Shalvata Mental Health Center
name: Shahak Yariv, MD
role: PRINCIPAL_INVESTIGATOR
References: