Schizophrenia
Conditions
Keywords
synaptogenesis, synapse, dendritic spines
Brief summary
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
Detailed description
This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks. This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
Interventions
DRUGSPG302
small synthetic molecule
DRUGPlacebo
Placebo
Sponsors
Spinogenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 * Primary diagnosis of schizophrenia * Clinical laboratory values within normal range or \< 1.5 times ULN * Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks * Able and willing to provide written informed consent
Exclusion criteria
* Any physical or psychological condition that prohibits study completion * Known cardiac disease * Active or history of malignancy in the past 5 years * History of clinically significant CNS event or diagnosis in the past 5 years. * Receipt of investigational products within 30 days * Blood donation within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician | 6 weeks | The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention. |
| Electroencephalogram analysis to assess brain electrical activity | 6 weeks | Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment. |
| Change in smooth pursuit eye tracking from baseline | 6 weeks | Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of SPG302 in patients with schizophrenia | 6 weeks | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results (SAEs). |
| Change in Global Impressions Improvement scale as determined by clinician | 6 weeks | Change in the Clinical Global Impression of Improvement (CGI-I) is a 3-item observer-rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). |
| Change in MATRICS Consensus Cognitive Battery scale as determined by clinician | 6 weeks | The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains through timed assessments. The results of each assessment are summarized for overall cognitive performance. The average score is between 40-60, and a score below 40 indicates lower overall cognitive performance. |
| World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline | 6 weeks | This is a 26-item questionnaire which collects self-reported data on physical health, psychological health, social relationships, and environmental health. Each section is scored from 1 to 5, with higher scores indicate higher quality of life. Scores from each section are then added together for an overall score, with higher score indicating higher quality of life. |
| Change in Personal and Social Performance from baseline | 6 weeks | Personal and Social Performance (PSP) evaluates overall functioning in daily life. A higher score indicates higher functioning. |
Countries
Australia, United States
Contacts
PRINCIPAL_INVESTIGATORDavid Walling, MD
CenExel
Outcome results
None listed