Delayed sleep phase in adolescents - effects of melatonin treatment

• Conditions: MedDRA version: 12.0Level: LLTClassification code 10012209Term: Delayed sleep phase; delayed sleep phase

• Registration Number: EUCTR2009-017075-24-SE
• Lead Sponsor: atural Pharma International Npi AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inability to fall asleep before midnight as a mean at least three times every school-week
Are the trial subjects under 18? yes
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

Somatic or mental disease producing sleep problems

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To find if six days of melatonin administration in the afternoon is sufficient to advance the sleep phase significantly compared to placebo.;Secondary Objective: To find if 6+6 days of melatonin treatment is more effective than only 6 days.;Primary end point(s): Melatonin in saliva is measured before and after melatonin or placebo administration at 6 p.m. during 6 days. The probes are taken at exactly the same time late in the evening (when capsules are not taken) and early in the following morning. If the evening melatonin is significantly higher and the morning melatonin significantly lower after medication the sleep phase is advanced.