Phase 3
Completed N=877
Escitalopram in Adult Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT00668525 ↗Enrolled (actual)
877
Serious AEs
1.6%
Results posted
May 2010
Primary outcomePrimary: Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. — -12.8; -13.4; -10.1 Units on a scale
Summary
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. |
-12.8; -13.4; -10.1 | — |
| SECONDARY Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 |
-11.5; -11.6; -8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
- The patient's current depressive episode must be at least 8 weeks in duration.
Exclusion Criteria
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- Patients who are considered a suicide risk
- Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Data sourced from ClinicalTrials.gov (NCT00668525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.