A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
Summary
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.
Timeline
- Start
- 2008-01-09
- Primary completion
- 2010-02-14
- Completion
- 2010-02-14
Outcome
Mixed primary results
registry PRIMARY OUTCOME 1: Change From Baseline in Alertness at Awakening NCT00561574 ↗
registry analysis (unspecified test); Esmirtazapine 1.5 mg; p <0.0001; t-test, 2 sided NCT00561574 ↗
registry PRIMARY OUTCOME 2: Change From Baseline in Feeling Full of Energy NCT00561574 ↗
registry analysis (unspecified test); Esmirtazapine 3.0 mg; p <0.0001; t-test, 2 sided NCT00561574 ↗
registry PRIMARY OUTCOME 4: Change From Baseline in Total Nap Time NCT00561574 ↗
registry analysis (unspecified test); Esmirtazapine 1.5 mg; p = 0.3129; t-test, 2 sided NCT00561574 ↗
Publications
- Results Ivgy-May N, Chang Q, Pong A, Winokur A. Esmirtazapine for the treatment of chronic primary insomnia: a randomized long-term safety study in elderly outpatients. J Sleep Med. 2020;17(1):19-30. doi: 10.13078/jsm.190032
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esmirtazapine | Small molecule | 1.5 mg | Oral |
| Subject | Esmirtazapine | Small molecule | 3 mg | Oral |