NCT00262665

Brief Summary

The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2005

Status
withdrawn

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

March 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

December 6, 2005

Last Update Submit

December 10, 2012

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks

    Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.

    at baseline and at 8 weeks

Secondary Outcomes (1)

  • change in neuropsychological function from baseline to 7 weeks

    at baseline and at 7 weeks

Study Arms (2)

Org 24448

EXPERIMENTAL

ampa receptor potentiator for the treatment of MDD

Drug: ORG 24448

Placebo

PLACEBO COMPARATOR

matching placebo pill

Drug: Placebo

Interventions

ORG 24448DRUG

flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Also known as: AMPA receptor potentiator
Org 24448
PlaceboDRUG

matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical Diagnosis of MDD
  • Have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to ≤3 antidepressant medications in the current or a previous episode

You may not qualify if:

  • Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

1-(benzofurazan-5-ylcarbonyl)piperidineAMPA receptor potentiator HBT1

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Dennis S Charney, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

March 1, 2005

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

December 11, 2012

Record last verified: 2012-12