Major Depressive Disorder
Conditions
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.
Detailed 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.
Interventions
DRUGORG 24448
flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
DRUGPlacebo
matching placebo pill - flexible regimen starting at 250mg once a day, increasing to maximum of 750mg twice a day.
Sponsors
National Institutes of Health (NIH)
Dennis Charney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in neuropsychological function from baseline to 7 weeks | at baseline and at 7 weeks | Effect on neuropsychological functioning measured by neuropsychological testing |
Outcome results
None listed