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Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)

NCT00844922 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-12-31

No results posted yet for this study

Summary

Patients who participated in the previous trial 28130, who were eligible, were entered into this trial. Patients who were randomized to placebo in the previous trial 28130 continued on placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose, were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2 weeks in order to study the safety and tolerability of Org 34517.

Conditions

  • Depressive Disorders
  • Psychotic Disorders
  • Depression

Interventions

DRUG

SCH 900636

Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression.

DRUG

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-06-30
Completion
2006-06-30

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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 NCT00844922 on ClinicalTrials.gov