Phase 2
Completed N=127
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
Source: ClinicalTrials.gov NCT02477670 ↗Enrolled (actual)
127
Serious AEs
1.1%
Results posted
Sep 2020
Primary outcomePrimary: Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12 — 61.0; 60.4; -5.0; -3.4 score on a scale — p=0.073
Summary
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12 |
61.0; 60.4; -5.0; -3.4; 57.6; 57.6 | 0.073 |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 and Week 12 |
67.4; 68.7; -4.7; -2.5; 67.1; 65.6 | 0.025 sig |
| SECONDARY Change From Baseline in the PANSS Negative Subscale Score at Week 6 and Week 12 |
24.6; 25.2; -2.2; -1.5; 24.4; 23.6 | 0.027 sig |
| SECONDARY Change From Baseline in the PANSS Marder Negative Factor Score at Week 6 and Week 12 |
24.1; 24.2; -2.1; -1.6; 23.0; 22.3 | 0.024 sig |
| SECONDARY Change From Baseline in the PANSS Prosocial Factor Subscale Score at Week 6 at Week 12 |
18.3; 18.4; -2.0; -1.1; 17.7; 17.0 | 0.009 sig |
| SECONDARY Change From Baseline in the PANSS Positive Subscale Score at Week 6 and Week 12 |
13.6; 13.4; -0.8; -0.3; 13.1; 13.3 | 0.700 |
| SECONDARY Change From Baseline in the PANSS General Psychopathology Subscale Score at Week 6 and Week 12 |
29.1; 30.1; -1.7; -0.7; 29.7; 28.7 | 0.054 |
| SECONDARY Change From Baseline in the PANSS Excitement Component Subscale Score at Week 6 and Week 12 |
6.2; 6.3; -0.4; -0.2; 5.8; 6.7 | 0.723 |
| SECONDARY Change From Baseline in the NSA-16 Communication Domain Score at Week 6 and Week 12 |
12.5; 12.6; -1.3; -1.0; 12.0; 11.8 | 0.064 |
| SECONDARY Change From Baseline in the NSA-16 Emotion/Affect Domain Score at Week 6 and Week 12 |
12.6; 12.2; -1.0; -0.6; 11.7; 11.7 | 0.100 |
| SECONDARY Change From Baseline in the NSA-16 Social Involvement Domain Score at Week 6 and Week 12 |
12.2; 12.2; -0.6; -0.3; 12.1; 12.0 | 0.388 |
| SECONDARY Change From Baseline in the NSA-16 Motivation Domain Score at Week 6 and Week 12 |
16.5; 16.7; -1.4; -0.9; 15.8; 15.8 | 0.367 |
| SECONDARY Change From Baseline in the NSA-16 Retardation Domain Score at Week 6 at Week 12 |
7.2; 6.7; -0.8; -0.6; 6.0; 6.3 | 0.447 |
| SECONDARY Change From Baseline in the NSA-16 Global Negative Symptoms Score at Week 6 and Week 12 |
4.6; 4.6; -0.4; -0.2; 4.3; 4.4 | 0.026 sig |
| SECONDARY Change From Baseline in the NSA-16 Global Level of Functioning Score at Week 6 and Week 12 |
4.7; 4.6; -0.4; -0.2; 4.5; 4.4 | 0.106 |
| SECONDARY Change From Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score at Week 6 and Week 12 |
32.5; 28.8; 1.2; 1.6; 31.7; 28.9 | 0.074 |
| SECONDARY Mean Actual Clinical Global Impression of Severity (CGI-S) of Illness Score at Week 6 and Week 12 |
3.6; 3.8; 3.7; 3.5 | 0.427 |
| SECONDARY Mean Actual Clinical Global Impression of Change (CGI-C) Score at Week 6 and Week 12 |
3.4; 3.6; 3.8; 3.5 | 0.0566 |
| SECONDARY Mean Actual Patient Global Impression of Change (PGI-C) Score at Week 6 at Week 12 |
3.1; 3.2; 3.3; 2.9 | 0.1700 |
| SECONDARY Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 6 and Week 12 |
1.1; 0.9; -0.2; -0.1; 1.0; 0.8 | 0.595 |
| SECONDARY Change From Baseline in the Effort Expenditure for Reward Task (EEfRT) Score for Baseline Press Rate at Week 6 and Week 12 |
3.39; 3.39; 0.461; 0.195; 3.38; 3.67 | 0.022 sig |
| SECONDARY Change From Baseline in the EEfRT Score for Choice Reaction Time (RT) 1st 50 at Week 6 and Week 12 |
1339.5; 1659.4; -255.1; -346.6; 1309.4; 1283.5 | 0.862 |
| SECONDARY Change From Baseline in the EEfRT Score for Completed Tasks at Week 6 and Week 12 |
0.790; 0.749; -0.032; 0.001; 0.703; 0.779 | 0.251 |
| SECONDARY Change From Baseline in the EEfRT Score for 12% Probability-Proportion High Effort Opts at Week 6 and Week 12 |
0.080; 0.0755; -0.021; -0.004; 0.040; 0.071 | 0.246 |
| SECONDARY Change From Baseline in the EEfRT Score for 50% Probability-Proportion High Effort Opts 1st 50 at Week 6 and Week 12 |
0.088; 0.078; -0.026; -0.012; 0.060; 0.062 | 0.818 |
| SECONDARY Change From Baseline in the EEfRT Score for 88% Probability-Proportion High Effort Opts 1st 50 at Week 6 and Week 12 |
0.082; 0.081; -0.021; -0.006; 0.052; 0.078 | 0.968 |
| SECONDARY Change From Baseline in the EEfRT Score for All-Proportion High Effort Opts 1st 50 at Week 6 and Week 12 |
0.251; 0.234; -0.068; -0.022; 0.152; 0.210 | 0.760 |
| SECONDARY Change From Baseline in the EEfRT Score for Difference - Proportion High Effort Opts 1st 50 at Week 6 and Week 12 |
0.002; 0.006; -0.001; -0.002; 0.012; 0.006 | 0.214 |
| SECONDARY Number of Participants With a Reduction of 20% or Greater in the PANSS Total Score at Week 6 and Week 12 |
5; 3; 42; 77; 1; 3 | 0.071 |
| SECONDARY Change From Baseline in the 4-Item NSA (NSA-4) Total Score at Week 6 and Week 12 |
17.4; 17.3; -1.0; -1.0; 16.5; 16.4 | -0.06 |
Eligibility Criteria
Inclusion Criteria
- Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
- Patients must meet PANSS criteria
- Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose
Exclusion Criteria
- Patients with current major depressive disorder (MDD)
- Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
- Patients currently using anticholinergic medications
- Recent in-patient hospitalization
Data sourced from ClinicalTrials.gov (NCT02477670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.