Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00262665
• Other study ID #: GCO # 05-0384
• Status: Withdrawn
• Phase: Phase 2
• First received: December 6, 2005
• Last updated: December 10, 2012
• Start date: March 2005
• Est. completion date: March 2005

Study information

• Verified date: December 2012
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Major depressive disorder (MDD) is a common, severe, chronic and often life-threatening illness. Major depression contributes to significant morbidity and mortality. Available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. Current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. Org 24448 represents a new treatment approach for depression, by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors. This drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ORG 24448
flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
• Placebo
matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dennis Charney	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change in neuropsychological function from baseline to 7 weeks	Effect on neuropsychological functioning measured by neuropsychological testing	at baseline and at 7 weeks	No