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A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia

NCT03319953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-03-19

Study results available
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Summary

The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.

Conditions

  • Stable Schizophrenia

Interventions

DRUG

TAK-041

TAK-041 suspension

DRUG

Placebo

TAK-041 placebo-matching suspension

DRUG

Second Generation Antipsychotics (SGA)

Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2019-09-11
Completion
2019-11-06

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT03319953 on ClinicalTrials.gov