Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01380704 | Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder | PHASE1 | COMPLETED | 51 | — | — | Jun 1, 2011 | Sep 1, 2011 | Nov 21, 2017 | - | — |
Hormones in blood, urine and saliva samples
ABT-436 drug levels in plasma
Blood pressure, pulse
Hematology, chemistry, urinalysis
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABT-436 | DRUG | QD Days 1-7 |
| Matching Placebo | DRUG | QD Days 1-7 |
Inclusion Criteria 1\. Age between 18 to 55 years, inclusive. 2. Body Mass Index is 20 to 35 kg/m2, inclusive. 3. A primary Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of major depressive disorder. 4\. Mild-to-moderate depressive symp...