Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: ONO-2333Ms Experimental 1; Drug: Placebo; Drug: ONO-2333Ms Experimental 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514865

ONO-2333POU007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

Enrollment: 278 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with recurrent major depressive disorder

Exclusion criteria

• Patients with treatment resistance for depression
• History of alcohol abuse/dependence, substance abuse/dependence within 6 months
• Has clinically significant unstable medical condition
• Has significant risk of suicide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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278 participants in 3 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

1-2 mg of ONO-2333

Treatment:

Drug: ONO-2333Ms Experimental 1

Experimental 2

Experimental group

Description:

5-10 mg of ONO-2333

Treatment:

Drug: ONO-2333Ms Experimental 2

Placebo

Placebo Comparator group

Description:

placebo comparator

Treatment:

Drug: Placebo