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The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

NCT03739203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 752

Last updated 2022-09-21

Study results available
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Summary

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.

Conditions

Interventions

DRUG

Cariprazine

Cariprazine supplied in capsules

DRUG

Placebo

Placebo supplied in capsules

DRUG

Antidepressant Therapy (ADT)

ADT as prescribed by the physician per standard of care in clinical practice.

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-10
Primary Completion
2021-09-06
Completion
2021-09-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Finland
  • Poland
  • Puerto Rico
  • Serbia
  • Slovakia

Study Locations

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 NCT03739203 on ClinicalTrials.gov