Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg; Drug: Placebo; Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056289

3151A1-4437

B2061010

Details and patient eligibility

About

Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Diagnosis of Major Depressive Disorder
• Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline

Exclusion criteria

• Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
• Potentially violent to others or is at significant risk for suicide
• History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
• Known presence of raised intraocular pressure or history of narrow angle glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

480 participants in 3 patient groups, including a placebo group

Desvenlafaxine Succinate Sustained-Release Formulation 50 mg

Active Comparator group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg

Desvenlafaxine Succinate Sustained-Release Formulation 25 mg

Active Comparator group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo