Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00262665|
Recruitment Status : Withdrawn (protocol cancelled)
First Posted : December 7, 2005
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: ORG 24448 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
Experimental: Org 24448
ampa receptor potentiator for the treatment of MDD
Drug: ORG 24448
flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
Other Name: AMPA receptor potentiator
Placebo Comparator: Placebo
matching placebo pill
matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
- mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks [ Time Frame: at baseline and at 8 weeks ]Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.
- change in neuropsychological function from baseline to 7 weeks [ Time Frame: at baseline and at 7 weeks ]Effect on neuropsychological functioning measured by neuropsychological testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262665
|Principal Investigator:||Dennis S Charney, MD||Icahn School of Medicine at Mount Sinai|