MedTrace Logo

Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia

NCT02079844 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-10-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether cognitive impairment associated with schizophrenia is attenuated by add-on roflumilast administration to second generation antipsychotics (SGA) in participants with stable schizophrenia.

Conditions

Interventions

DRUG

Roflumilast

Roflumilast tablets

DRUG

Placebo

Roflumilast placebo-matching tablets

DRUG

Second generation antipsychotic

Second Generation Antipsychotic (SGA) medication for standard of care therapy will be sourced and managed locally by the site.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United Kingdom

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02079844 on ClinicalTrials.gov