Schizophrenia
Conditions
Brief summary
Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia. The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.
Detailed description
The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The secondary objectives of the study were to assess the safety and tolerability of LY2140023 compared with placebo and olanzapine; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score; efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS negative symptom subset score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in mood and anxiety as measured by the Hamilton Anxiety Scale (HAMA) total score; efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the Clinical Global Impression-Severity (CGI-S); effect of LY2140023 on prolactin levels of the patients after 4 weeks of treatment; efficacy of olanzapine compared with placebo on the PANSS total score; pharmacokinetics of LY2140023 and LY404039 in patients, and to explore the relationship between exposure and efficacy.
Interventions
Sponsors
Denovo Biopharma LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Investigators and patients were blinded to each patient's treatment. Only a pharmacist or designated person at the study site were unblinded to each patient's treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* meet the DSM-IV criteria for schizophrenia as confirmed by modified SCID
Exclusion criteria
* meet the full syndromal criteria for other Axis I disorder * have taken any depot antipsychotic within 4 weeks before screening * are taking mood-stabilizing agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score | 28 days | The primary objective of this study was to determine if LY2140023 dosed at 40 mg twice daily (BID) for 28 days was superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scale (PANSS) total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of LY2140023 compared with placebo and olanzapine | 28 days | Safety parameters evaluated included physical and neurological examinations, vital signs, body weight, 12-lead electrocardiograms (ECGs), clinical laboratory tests, prolactin levels, and the record of symptoms. Other safety measures included the Barnes Akathisia Scale (BAS), Simpson- Angus Scale (SAS), and the Abnormal Involuntary Movement Scale (AIMS). |
| Efficacy of LY2140023 compared with placebo in change from baseline to Visit 8 in the PANSS positive symptom subset score | 28 days | The secondary efficacy variables include the change from baseline in the PANSS positive symptoms subset score, the PANSS negative symptom subset score, CGI-S score, and HAMA total score. A patient will be included in the analysis if he or she has a baseline and at least one post-baseline measure. |
| Efficacy of LY2140023 compared with placebo in the responder rate in the PANSS total score | 28 days | Efficacy of LY2140023 compared with placebo in the responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS total score |
| Efficacy of LY2140023 compared with placebo in responder rate in the PANSS positive and negative symptom subset score | 28 days | Efficacy of LY2140023 compared with placebo in responder rate (defined as 25% or more decrease from baseline to Visit 8) in the PANSS positive and negative symptom subset score |
Countries
Russia
Outcome results
None listed