Phase 3
Completed N=526
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
Source: ClinicalTrials.gov NCT00482612 ↗Enrolled (actual)
526
Serious AEs
0.4%
Results posted
Jul 2014
Primary outcomePrimary: Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period — 382.14; 382.77; 394.83; 351.40 Minutes — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period |
382.14; 382.77; 394.83; 351.40 | <0.0001 sig |
| SECONDARY Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period |
48.93; 52.02; 50.80; 60.13 | 0.0014 sig |
| SECONDARY Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period |
35; 41; 41; 28 | — |
| SECONDARY Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period |
4; 7; 9; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00482612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.