Schizophrenia Clinical Trial
Official title:
Virtual Rehabilitation for the Treatment of Motivational Deficits in Schizophrenia
NCT number | NCT02709733 |
Other study ID # | 033-2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | August 2018 |
Verified date | September 2019 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. Despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery for individuals with schizophrenia. To address this critical unmet therapeutic need, this study aims to investigate a novel computerized motivation rehabilitation program using virtual reality to treat motivation loss in schizophrenia.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: 1. Between 18 and 35 years old; 2. DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder; 3. Outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks; 4. Minimum Apathy Evaluation Scale (AES) score of 34. Exclusion Criteria: 1. Diagnosis of other DSM-IV Axis I disorders; 2. History of active substance abuse or dependence in the past 6 months, with the exception of nicotine; 3. History of neurological disease; 4. History of head trauma with loss of consciousness >30 minutes 5. Presence of significant akathisia (a rating of >2 on the Barnes Akathisia Rating Scale (BARS) Global item); or 6. Presence of significant extrapyramidal symptoms (a rating of >2 on >2 items of the Simpson Angus Rating Scale (SARS)) 7. Any MRI contraindications. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Ontario Ministry of Health and Long Term Care |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apathy Evaluation Scale (AES) | 9 weeks | ||
Secondary | Scale for the Assessment of Negative Symptoms (SANS) | 9 weeks | ||
Secondary | Quality of Life Scale (QLS) | 9 weeks | ||
Secondary | Scale for the Assessment of Positive Symptoms (SAPS) | 9 weeks | ||
Secondary | Brief Assessment of Cognition in Schizophrenia (BACS) | 9 weeks | ||
Secondary | Calgary Depression Scale for Schizophrenia (CDSS) | 9 weeks | ||
Secondary | Simulator Sickness Questionnaire (SSQ) | 9 weeks | ||
Secondary | Functional Brain Imaging | Change in regional brain activity measured with functional MRI | 9 weeks | |
Secondary | Structural Brain Imaging | Changes in brain structure (e.g., white matter tract integrity) measure with structural MRI | 9 weeks |
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