MDDNCT01501812
Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders
An observational study of MDD and Bipolar Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MDD, Bipolar Disorder, Schizophrenia Disorder
- What is being tested?
- Generalization pattern
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shalvat Mental Health Center
Hod HaSharon
Shahak Yariv, MD, 972-54-9876823, dr.shahakyariv@gmail.com
Shahak Yariv, MD
About this study
Official title: Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders (Schizophrenia, Affective Spectrum and Anxiety Disorders) - an Open, Single Center, Longitudinal Study
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.
Read more
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
- Conditions
- MDD, Bipolar Disorder, Schizophrenia Disorder, Anxiety Disorder (Panic Disorder or GAD), PTSD
- Being tested
- Generalization pattern
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generalization patternBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Subjects who are suffering from Schizophrenia or Schizoaffective disorder acording to the DSM-IV-R criteria Receives: Behavioral: Generalization pattern | |
| Control | Healthy subjects without any mental ilness in axis I or II. Receives: Behavioral: Generalization pattern | |
| Bipolar | Subjects who are suffering from bipolar I or 2 disorder acording to the DSM-IV-R criteria Receives: Behavioral: Generalization pattern | |
| MDD | Subjects who are suffering from Major Depressive disorder acording to the DSM-IV-R criteria Receives: Behavioral: Generalization pattern | |
| Anxiety | Subjects who are suffering from Panic disorder or from Generalized Anxiety disorder acording to the DSM-IV-R criteria Receives: Behavioral: Generalization pattern | |
| PTSD | Subjects who are suffering from Post Traumatic Stress Disorder acording to the DSM-IV-R criteria Receives: Behavioral: Generalization pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalization pattern differentiation
Compare the generalization curve and the differentiation between positive, negative and neutral valency bias
Measured: 60 minutes
Secondary outcomes (1)
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
Measured: 4-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor
- Investigators
- Shahak Yariv, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501812
- Sponsor's protocol ID
- SHA-04-11
- Status last verified
- Dec 2011
- First submitted
- 27 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders (Schizophrenia, Affective Spectrum and Anxiety Disorders) - an Open, Single Center, Longitudinal Study
- ClinicalTrials.gov ID
- NCT01501812
- Acronym / sponsor ID
- SHA-04-11
- Conditions
- MDD, Bipolar Disorder, Schizophrenia Disorder, Anxiety Disorder (Panic Disorder or GAD), PTSD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | Behavioral: Generalization patternSubjects who are suffering from Schizophrenia or Schizoaffective disorder acording to the DSM-IV-R criteria |
| Control | – | Behavioral: Generalization patternHealthy subjects without any mental ilness in axis I or II. |
| Bipolar | – | Behavioral: Generalization patternSubjects who are suffering from bipolar I or 2 disorder acording to the DSM-IV-R criteria |
| MDD | – | Behavioral: Generalization patternSubjects who are suffering from Major Depressive disorder acording to the DSM-IV-R criteria |
| Anxiety | – | Behavioral: Generalization patternSubjects who are suffering from Panic disorder or from Generalized Anxiety disorder acording to the DSM-IV-R criteria |
| PTSD | – | Behavioral: Generalization patternSubjects who are suffering from Post Traumatic Stress Disorder acording to the DSM-IV-R criteria |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generalization patternDuring 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 | Behavioural | Anxiety, Bipolar, Control, MDD, PTSD, Schizophrenia |
Primary outcome
Generalization pattern differentiation
Time frame: 60 minutes
Compare the generalization curve and the differentiation between positive, negative and neutral valency bias
1 secondary outcome
State or trait differentiation
Time frame: 4-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahak Yariv, MD principal investigator
Shalvata Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MDD and Bipolar Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahak Yariv, MD (972-54-9876823, dr.shahakyariv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalization pattern differentiation (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.