A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
Public ClinicalTrials.gov record NCT03557931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.
Study identification
- NCT ID
- NCT03557931
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 233 participants
Conditions and interventions
Conditions
Interventions
- ASP4345 Drug
- placebo Drug
- risperidone Drug
- quetiapine Drug
- olanzapine Drug
- ziprasidone Drug
- aripiprazole Drug
- brexpiprazole Drug
- paliperidone Drug
- lurasidone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2018 (Actual)
- Primary completion
- Oct 21, 2019 (Actual)
- Completion
- Oct 21, 2019 (Actual)
- Last update posted
- Nov 12, 2024
2018 – 2019
United States locations
- U.S. sites
- 27
- U.S. states
- 10
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CNS Research Science, Inc. | Cerritos | California | 90703 | — |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | — |
| Synergy East | Lemon Grove | California | 91945 | — |
| Pacific Research Partners, LLC | Oakland | California | 94607 | — |
| California Neuropsychopharmacology Clinical Research Institute-LA, LLC | Pico Rivera | California | 90660 | — |
| California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego) | San Diego | California | 92102 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | — |
| Collaborative Neuroscience Network, LLC | Torrance | California | 90502 | — |
| Radiant Research, Inc. | Atlanta | Georgia | 30328 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Alam Medical Research Inc. | Chicago | Illinois | 60612 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | — |
| Cherry Street Services, Inc. | Grand Rapids | Michigan | 49503 | — |
| Arch Clinical Trials, LLC | St Louis | Missouri | 63118 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | 87109 | — |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | — |
| CNS Research Science, Inc. | Jamaica | New York | 11432 | — |
| New York State Psychiatric Institute | New York | New York | 10032 | — |
| Manhattan Psychiatric Center's 125th Street Clinic | New York | New York | 10035 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03557931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03557931 live on ClinicalTrials.gov.