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A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)

NCT00212797 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2015-11-26

No results posted yet for this study

Summary

The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.

Conditions

  • Depression
  • Depressive Disorders
  • Psychotic Disorders

Interventions

DRUG

Org 34517

low dose Org 34517

DRUG

Org 34517

high dose Org 34517

DRUG

Placebo

placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-07-31
Completion
2006-07-31

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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 NCT00212797 on ClinicalTrials.gov