Efficacy and Safety Study of Org 50081 in Elderly Patients (21108AM1)(P05709)(COMPLETED)

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: November 19, 2007
Last updated: October 23, 2013
Last verified: October 2013

To investigate the efficacy of treatment with Org 50081

compared to placebo in elderly subjects with chronic primary

insomnia. Primary efficacy variable is Wake time After Sleep

Onset (WASO), averaged over all in-treatment time points

and measured by polysomnography (PSG).

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Mental Disorders
Sleep Disorders
Drug: Org 50081
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel Group, Placebo- Controlled Sleep Laboratory Efficacy and Safety Study With Org 50081 in Elderly Subjects With Chronic Primary Insomnia

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Primary efficacy variable is Wake time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography (PSG). [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate PSG defined latency to persistent sleep (LPS); to investigate subjective reports of efficacy, using electronic diaries; to investigate the safety and tolerability of Org 50081 in elderly subjects; [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 538
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Org 50081-1
one tablet daily
Drug: Org 50081
one tablet daily
Experimental: Org 50081-2
one tablet daily
Drug: Org 50081
one tablet daily
Experimental: Org 50081-3
one tablet daily
Drug: Org 50081
one tablet daily
Placebo Comparator: Placebo
one tablet daily
Drug: Placebo
one tablet daily

Detailed Description:

Insomnia is a common complaint or disorder throughout the

world. About one third of the population in the industrial

countries reports difficulty initiating or maintaining sleep,

resulting in a non-refreshing or non-restorative sleep. The

majority of the insomniacs suffer chronically from their


The maleic acid salt of Org 4420, code name Org 50081, was

selected for development in the treatment of insomnia. The

first clinical trial with Org 50081 was a proof-of-concept trial

with a four-way cross-over design. All 3 Org 50081 dose

groups showed a statistically significant positive effect on

TST (objective and subjective) and WASO, as compared to


The current study is designed to assess the efficacy and safety

of Org 50081 in a double-blind, placebo-controlled, parallel,

randomized trial in elderly subjects suffering from chronic

primary insomnia.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • are at least 65 years of age at screening;
  • sign written informed consent after the scope and

nature of the investigation have been explained to

them, before screening evaluations;

  • 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


  • 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;

  • 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;

  • 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:

  • average TST < 6.5 h (and each night greater than or

equal to 3 h and < 7 h),

  • average WASO greater than or equal to 45 minutes

(and each night greater than or equal to 30 min),

  • average LPS 15 min (and each night greater than or

equal to 10 min).

Exclusion Criteria:

  • have other sleep disorders (DSM-IV-TR), such as sleep

related breathing disorders (AHI greater than or equal

to 15), periodic leg movements with arousals (PLMAI

greater than opr equal to 10), restless leg syndrome,

narcolepsy, circadian sleep wake rhythm disorders,

REM behavioral disorder or any parasomnia;

  • have any significant medical or DSM-IV-TR

psychiatric illness causing the sleep disturbances;

  • currently meet diagnostic criteria for DSM-IV-TR

depression (MDD) or have been diagnosed and treated

for MDD within the last 2 years;

  • 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);
  • 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;

  • have a significant, unstable medical illness e.g. acute or

chronic pain, hepatic, renal, metabolic or cardiac


  • had serious head injury or stroke within the past year,

or a history of (non-febrile) seizures;

  • have clinically relevant ECG abnormalities at

screening, as judged by the investigator;

  • have clinically relevant abnormal hematology or

biochemistry values at screening, as judged by the


  • have DSM-IV-TR substance abuse or DSM-IV-TR

addiction within the last year;

  • 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);
  • are routinely sleeping during daytime (napping) for more than 20 minutes per day, 3 days or more per week;
  • are night workers or rotating shift workers currently, or in the past 6 months
  • use of psychotropic drugs affecting sleep within two weeks prior to randomization (fluoxetine: five weeks);
  • use of concomitant medication affecting sleep (e.g. anxiolytics, sedatives, antidepressants, antipsychotics, centrally active sedating antihistamines, CNS

stimulants, alpha-2-antagonists, respiratory stimulants and decongestants);

  • smoke > 15 cigarettes per day and/or can not abstain from smoking during the night;
  • drink excessive amounts of caffeinated beverages/day (more than 500 mg caffeine per day);
  • have a body mass index (BMI) = 36;
  • have a positive urine drug screen at screening or at baseline;
  • have a known hypersensitivity to mirtazapine or to any of the excipients;
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  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00561821     History of Changes
Other Study ID Numbers: P05709, 21108
Study First Received: November 19, 2007
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
placebo controlled

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Schizophrenia and Disorders with Psychotic Features
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014