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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.
This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.
Patients with clinical stability for at least 3 months and stable antipsychotic and psychotropic medication treatment for at least the last 4 weeks and without relevant depression, positive psychotic symptoms or extrapyramidal symptoms EPS will be eligible. After written informed consent, patients will undergo a screening visit to confirm full study eligibility. If all in- and exclusion criteria are fulfilled, patients will undergo a baseline assessment and then be randomized 1:1 to 16 weeks of adjunctive treatment with vortioxetine or placebo. Subsequently, patients will be seen at week 1, 2, 4 and monthly for the next 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Active Comparator | Vortioxetine will be initiated at 10 mg / day for 1 month, followed by 20 mg /day for the remainder of the trial. The dose of vortioxetine can be lowered to 10 mg for tolerability reasons. |
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| Placebo | Placebo Comparator | Matching placebo pills will be initiated at 10 mg / day for 1 month, followed by 20 mg /day for the remainder of the trial. The dose of placebo can be lowered to 10 mg for tolerability reasons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug |
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| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Negative Symptom Assessment Scale (NSA-16) total score from baseline to endpoint | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the general composite score on the MATRICS Consensus Cognitive Battery (MCCB) from baseline to endpoint | 16 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph U Correll, MD | North Shore LIJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henderson Behavioral Health | Lauderdale Lakes | Florida | 33319 | United States | ||
| Cherry Health |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
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| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |