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.

Phase 3

Completed

Conditions: slaapstoornissen
insomnia
sleeplessness

Registration Number: NL-OMON33796

Lead Sponsor: Schering-Plough

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

At least 18 and less than 65 years of age
Have a documented diagnosis of chronic primary insomnia with a duration of >_ 1 month
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
Have demonstrated capability to independently complete the LogPad questionnaires and have completed the dialy morning questionnaires at least 6 out of 7 days in the week preceding randomisation

Exclusion Criteria

Have other sleep disorders
Have any significant medical or DSM-IV-TR psychiatric illness causing the sleepdisturbances
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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate the long-term efficacy of treatment with Org 50081, as compared<br /><br>to placebo, on sleep maintenance in patients with chronic primary insomnia as<br /><br>measured by the subjective Total Sleep Time. Primary efficacy endpoint is the<br /><br>average of subjective Total Sleep Time (TST) during month 4 to month 6, as<br /><br>recorded daily in the sleep diary.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To demonstrate the long-term efficacy of Org 50081 in improving sleep latency<br /><br>(SL)<br /><br>To investigate the long-term efficacy of Org 50081 on other sleep maintenance<br /><br>parameters WASO, NAW and on sleep quality and satisfaction with sleep duration<br /><br>To investigate the long-term safety and tolerability of Org 50081, as compared<br /><br>to placebo<br /><br>To investigate the effects of discontinuation of Org 50081 after long-term<br /><br>treatment<br /><br>To explore the effect of Org 50081 on functional and quality of life outcomes<br /><br>as compared to placebo</p><br>