Escitalopram in Adult Patients With Major Depressive Disorder

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668525

SCT-MD-49

Details and patient eligibility

About

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.

Enrollment: 877 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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877 participants in 3 patient groups, including a placebo group

2

Active Comparator group

Description:

Escitalopram low dose

Treatment:

Drug: Escitalopram

Drug: Escitalopram

3

Experimental group

Description:

Escitalopram high dose

Treatment:

Drug: Escitalopram

Drug: Escitalopram

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo