EUCTR2007-003636-35-SEActive, not recruitingNot Applicable
A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081 - JADE
V Organon0 sites250 target enrollmentStarted: October 17, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 250
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects are eligible to participate in the trial, if they:
- •1. are at least 65 years of age at screening;
- •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
- •in the week preceding randomization;
- •5. normal bedtime should be within the 21:00 – 01:00 hour range, with no more variation
- •than 2 hours for 5 nights out of 7;
- •6. 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;
- •7. fulfill the following criteria based on medical or sleep 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •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 signs of dementia or other serious cognitive impairment, defined by a score of less than
- •26 on the Mini-Mental State Examination (MMSE);
- •12. have a history of bipolar disorder, a history of suicide attempt or a 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);
- •13. are night workers or rotating shift workers;
- •14. are traveling, or have plans to travel, through more than three time zones during the
- •trial, from the screening visit onwards;
- •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 or biochemistry values at screening,
- •as judged by the investigator;
- •18. have DSM-IV-TR substance abuse or DSM-IV-TR 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 psychotropic drugs affecting sleep within 2 weeks prior to randomization (fluoxetine:
- •22. use 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 routinely sleeping during daytime (napping) for more than 60 minutes per day,
- •3 times/ week;
- •27. have a body mass index (BMI) = 36;
- •28. have a known hypersensitivity to mirtazapine or to any of the excipients;
- •29. participated in another clinical trial within the last 30 days prior to screening;
- •30. participated in another clinical trial using esmirtazapine (Org 50081) at any time.
Investigators
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