Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders

Bipolar Disorder Clinical Trial

Official title:

Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders (Schizophrenia, Affective Spectrum and Anxiety Disorders) - an Open, Single Center, Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01501812
• Other study ID #: SHA-04-11
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2011
• Last updated: December 27, 2011
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2011
• Source: Shalvata Mental Health Center
• Contact: Shahak Yariv, MD
• Phone: 972-54-9876823
• Email: dr.shahakyariv[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety Disorder (Panic Disorder or GAD)
• Anxiety Disorders
• Bipolar Disorder
• Disease
• MDD
• Mental Disorders
• Panic Disorder
• PTSD
• Schizophrenia
• Schizophrenia Disorder

Intervention

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

Locations

Country	Name	City	State
Israel	Shalvat Mental Health Center	Hod hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalization pattern differentiation	Compare the generalization curve and the differentiation between positive, negative and neutral valency bias	60 minutes	No
Secondary	State or trait differentiation	to find the stability of the outcome between the two visits, and whether there is correlation with clinical state and the generalization patterns	4-24 weeks	No