A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 440

Inclusion Criteria

Subjects are eligible to participate in the trial, if they:
1. are at least 18 and less than 65 years of age;
2. sign written informed consent after the scope and nature of the investigation have been explained to them, before screening evaluations;
3. are able to speak, read and understand the language of the investigator, study staff (including raters) and the informed consent form, and possess the ability to respond to questions, follow instructions and complete questionnaires;
4. have demonstrated capability to independently complete the LogPad questionnaires and have completed the daily morning questionnaires at least 6 out of 7 days in the week preceding randomization;
5. have a documented diagnosis of chronic primary insomnia, defined as fulfillment of the DSM-IV-TR criteria for primary insomnia (DSM-IV-TR 307.42) with a duration of = 1 month;
6. Fulfill the following criteria based on medical history. Each of these criteria should be present for at least 3 nights per week for at least one month;
TST = 6.5 hours
WASO = 60 minutes
SL = 30 minutes
7. Normal bedtime should be within the 21:00 hours – 01:00 hour range, with no more variation than 2 hours for 5 nights out of 7.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential participants will be excluded if they:
8. have other sleep disorders (DSM-IV-TR) e.g. rapid eye movement (REM) behavioral disorders, sleep related breathing disorders, periodic leg movement disorder, restless leg syndrome, narcolepsy, circadian sleep wake rhythm disorders, or any parasomnia;
9. have any significant medical or DSM-IV-TR psychiatric illness causing the sleep disturbances;
10. currently meet diagnostic criteria for DSM-IV-TR depression (MDD) or have been diagnosed and treated for MDD within the last 2 years;
11. have a history of bipolar disorder, a history of suicide attempt or family history of suicide. A family history of suicide is defined as any history of suicide in the first and second degree family (parents, siblings, grandparents, or offspring), or a pattern of completed suicides (more than one) in the third degree family (aunts, uncles, nieces, and nephews);
12. are night workers or rotating shift workers;
13. are traveling, or have plans to travel through more than 3 time zones, more than 2 times during the trial (from Screening onwards);
14. are routinely sleeping during daytime (napping) for more than 60 minutes per day, 3 times/week;
15. have a significant, unstable medical illness e.g. acute or chronic pain, hepatic, renal, metabolic or cardiac disease;
16. have clinically relevant ECG abnormalities at screening, as judged by the investigator;
17. have clinically relevant abnormal hematology, biochemistry or urinalysis values at screening, as judged by the investigator;
18. have DSM-IV-TR substance abuse or addiction within the last year;
19. drink more than 2 alcoholic drinks in a day. One drink is approximately equal to: 12 oz or 360 ml of beer (regular or light), or 4 oz or 120 ml of red or white wine, or 2 oz or 60 ml of desert wine (e.g. port, sherry), or 12 oz or 360 ml of wine cooler (regular or light), or 1 oz or 30 ml or spirits (80 to 100 proof, e.g. whiskey, vodka);
20. had serious head injury or stroke within the past year, or a history of (non-febrile) seizures;
21. use of psychotropic drugs affecting sleep within 2 weeks prior to baseline (fluoxetine: 5 weeks);
22. use of concomitant medication affecting sleep (see Protocol Section 3.4, Concomitant medication);
23. smoke > 15 cigarettes per day and/or can not abstain from smoking during the night;
24. drink excessive amounts of caffeinated beverages (more than 500 mg caffeine per day);
25. have a positive urine drug screen at screening;
26. are pregnant, lactating or females of childbearing potential not practicing a reliable doublebarrier method of contraception as judged by the investigator;
27. have a body mass index (BMI) = 36;
28. have a known hypersensitivity to mirtazapine or to any of the exipients;
29. participated in another clinical trial within the last 30 days prior to screening;
30. participated in another clinical trial using esmirtazapine (Org 50081).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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