NCT00212797

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_2 depression

Timeline
Completed

Started Jul 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

September 15, 2005

Last Update Submit

November 25, 2015

Conditions

DepressionDepressive DisordersPsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • PANSS positive symptoms subscale.

    6 weeks

Secondary Outcomes (1)

  • Ham-D17, CGI, Cognition, spermatogenesis

    6 weeks

Study Arms (3)

Org 34517_1

EXPERIMENTAL

low dose Org 34517

Drug: Org 34517

Org 34517_2

EXPERIMENTAL

high dose Org 34517

Drug: Org 34517

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Org 34517DRUG

low dose Org 34517

Org 34517_1
PlaceboDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening);
  • be able to speak, read, understand, respond to questions, and follow
  • instructions in English or their native language;
  • have DSM-IV severe depressive episode with psychotic features, as
  • diagnosed by the MINI for single or recurrent episodes (296.24 or 296.34);
  • have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at Screening and Baseline;
  • have a PANSS Positive Scale score of at least 16 at Screening and Baseline;
  • have a total score of at least 18 on the HAMD 17-item scale at Screening and Baseline;
  • be on a stable dose of "usual treatment", which had to consist of an
  • antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes;
  • be between 18 and 75 years of age (inclusive) at Screening;
  • be willing to be hospitalized for at least 11 days from Screening onwards.

You may not qualify if:

  • have any other current psychiatric diagnosis (according to the MINI) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders;
  • have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode;
  • be at significant risk of committing suicide, as indicated by a score greater than 9 on the revised InterSePT Scale for Suicidal Thinking (ISST);
  • be currently treated with carbamazepine or valproate;
  • be currently treated with midazolam;
  • be treated with electroconvulsive therapy in the current episode;
  • be currently treated with more than one antidepressant;
  • be currently treated with more than one antipsychotic;
  • be currently treated with more than one mood stabilizer;
  • have a "usual treatment" started or discontinued in the 2 weeks before
  • Randomization;
  • have a "usual treatment" dose change within the week prior to
  • Randomization;
  • have any clinically unstable or uncontrollable renal, hepatic, respiratory,
  • hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy;
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionDepressive DisorderPsychotic Disorders

Interventions

Org 34517

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 26, 2015

Record last verified: 2015-11