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Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

NCT03230864 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2020-01-21

Study results available
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Summary

This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)

Conditions

  • Treatment-resistant Schizophrenia

Interventions

DRUG

Lu AF35700

10 mg/day, encapsulated tablets, orally

DRUG

Risperidone

4-6 mg/day, encapsulated tablets, orally

DRUG

Olanzapine

15-20 mg/day, encapsulated tablets, orally

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2018-12-23
Completion
2019-02-05
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Japan
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230864 on ClinicalTrials.gov