Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) (RUBY)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Insomnia

Treatments: Drug: Esmirtazapine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482612

176001 (Other Identifier)

MK-8265-003 (Other Identifier)

P05706

Details and patient eligibility

About

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Enrollment: 526 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has signed written informed consent after the scope and nature of the investigation was explained to them
• Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion criteria

• Significant medical or psychiatric illness causing sleep disturbances
• Has a history of bipolar disorder or family (immediate family) of suicide
• Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
• Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
• Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
• Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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526 participants in 4 patient groups, including a placebo group

Esmirtazapine 1.5 mg

Experimental group

Description:

Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks

Treatment:

Drug: Esmirtazapine

Esmirtazapine 3.0 mg

Experimental group

Description:

Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks

Treatment:

Drug: Esmirtazapine

Esmirtazapine 4.5 mg

Experimental group

Description:

Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks

Treatment:

Drug: Esmirtazapine

Placebo

Placebo Comparator group

Description:

Placebo to esmirtazapine

Treatment:

Drug: Placebo