A double-blind, randomized, parallel group, placebo-controlled sleep laboratory efficacy and safety study with Org 50081 in elderly subjects with chronic primary insomnia - Turquoise

• Conditions: Primary insomnia; MedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomnia

• Registration Number: EUCTR2007-002523-33-SE
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

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 and
have completed the questionnaires at least 6 out of 7 days of the week preceding randomization;
5. have a regular sleep pattern, meaning bedtime regularly occurs between 2100 and 2400, with no
more variation from these boundaries than 2 times/ week, with 5-8.5 hours in bed;
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;
fulfill the following PSG criteria on the two screening/baseline PSG nights:
7. average TST < 6.5 h (and each night = 3 h and < 7 h),
8. average WASO = 45 minutes (and each night = 30 min),
9. average LPS = 15 min (and each night = 10 min).

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
;
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 and
have completed the questionnaires at least 6 out of 7 days of the week preceding randomization;
5. have a regular sleep pattern, meaning bedtime regularly occurs between 2100 and 2400, with no
more variation from these boundaries than 2 times/ week, with 5-8.5 hours in bed;
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;
fulfill the following PSG criteria on the two screening/baseline PSG nights:
7. average TST < 6.5 h (and each night = 3 h and < 7 h),
8. average WASO = 45 minutes (and each night = 30 min),
9. average LPS = 15 min (and each night = 10 min).

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

Potental participants will be excluded if they:
10. have other sleep disorders (DSM-IV-TR), such as sleep related breathing disorders (AHI = 15),
periodic leg movements with arousals (PLMAI = 10), restless leg syndrome, narcolepsy, circadian
sleep wake rhythm disorders, REM behavioral disorder or any parasomnia;
11. have any significant medical or DSM-IV-TR psychiatric illness causing the sleep disturbances;
12. currently meet diagnostic criteria for DSM-IV-TR depression (MDD) or have been diagnosed and treated
for MDD within the last 2 years;
13. 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)
14. have a history or signs of dementia or other serious cognitive impairment, as defined by a score
of less than 26 on the Mini-Mental State Examination;
15. have a significant, unstable medical illness e.g. acute or chronic pain, hepatic, renal, metabolic
or cardiac disease;
16. had serious head injury or stroke within the past year, or a history of (non-febrile) seizures;
17. have clinically relevant ECG abnormalities at screening, as judged by the investigator;
18. have clinically relevant abnormal hematology or biochemistry values at screening, as
judged by the investigator;
19. have DSM-IV-TR substance abuse or DSM-IV-TR addiction within the last year;
20. 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);
21. are routinely sleeping during daytime (napping) for more than 20 minutes per day, 3 days or more
per week;
22. are night workers or rotating shift workers currently, or in the past 6 months;
23. are traveling, or have plans to travel, through more than three time zones during the trial,
from the screening visit onwards;
24. use of psychotropic drugs affecting sleep within two weeks prior to randomization
(fluoxetine: five weeks);
25. use of concomitant medication affecting sleep (see Protocol Section 3.4, Concomitant medication);
26. smoke > 15 cigarettes per day and/or can not abstain from smoking during the night;
27. drink excessive amounts of caffeinated beverages/day (more than 500 mg caffeine per day);
28. have a body mass index (BMI) = 36;
29. have a positive urine drug screen at screening or at baseline;
30. have a known hypersensitivity to mirtazapine or to any of the excipients;
31. participated in another clinical trial within the last 30 days prior to screening;
32. participated in another clinical trial with esmirtazapine (Org 50081).

;
Potental participants will be excluded if they:
10. have other sleep disorders (DSM-IV-TR), such as sleep related breathing disorders (AHI = 15),
periodic leg movements with arousals (PLMAI = 10), restless leg syndrome, narcolepsy, circadian
sleep wake rhythm disorders, REM behavioral disorder or any parasomnia;
11. have any significant medical or DSM-IV-TR psychiatric illness causing the sleep disturbances;
12. currently meet diagnostic criteria for DSM-IV-TR depression (MDD) or have been diagnosed and treated
for MDD within the last 2 years;
13. 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)
14. have a history or signs of dementia or other serious cognitive impairment, as defined by a score
of less than 26 on the Mini-Mental State Examination;
15. have a significant, unstable medical illness e.g. acute or chronic pain, hepatic, renal, metabolic
or cardiac disease;
16. had serious head injury or stroke within the past year, or a history of (non-febrile) seizures;
17. have clinically relevant ECG abnormalities at screening, as judged by the investigator;
18. have clinically relevant abnormal hematology or biochemistry values at screening, as
judged by the investigator;
19. have DSM-IV-TR substance abuse or DSM-IV-TR addiction within the last year;
20. 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);
21. are routinely sleeping during daytime (napping) for more than 20 minutes per day, 3 days or more
per week;
22. are night workers or rotating shift workers currently, or in the past 6 months;
23. are traveling, or have plans to travel, through more than three time zones during the trial,
from the screening visit onwards;
24. use of psychotropic drugs affecting sleep within two weeks prior to randomization
(fluoxetine: five weeks);
25. use of concomitant medication affecting sleep (see Protocol Section 3.4, Concomitant medication);
26. smoke > 15 cigarettes per day and/or can not abstain from smoking during the night;
27. drink excessive amounts of caffeinated beverages/day (more than 500 mg caffeine per day);
28. have a body mass index (BMI) = 36;
29. have a positive urine drug screen at screening or at baseline;
30. have a known hypersensitivity to mirtazapine or to any of the excipients;
31. participated in another clinical trial within the last 30 days prior to screening;
32. participated in another clinical trial with esmirtazapine (Org 50081).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified