NCT00816673

Brief Summary

The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 1996

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1997

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1997

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2009

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

December 31, 2008

Last Update Submit

November 13, 2024

Conditions

Primary Insomnia

Keywords

InsomniaPrimary insomniasleep latencynon restorative sleepsleep qualityDouble-BlindPlacebo ControlledParallel-GroupSleep Laboratory Study

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: placebo Circadin

Circadin

EXPERIMENTAL
Drug: Circadin

Interventions

placebo CircadinDRUG

Placebo tabs of Prolonged release melatonin

placebo
CircadinDRUG

prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks

Also known as: ATC code: N05CH01
Circadin

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female, aged ≥ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)

You may not qualify if:

  • According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
  • Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
  • Severe neurological, psychiatric or sleep disorders;
  • Other serious diseases;
  • Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
  • Subjects who need beta blockers as a treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FORENAP

Centre Hospitalier de Rouffach, F-68250, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Jean Paul MACHER, MD

    Forenap

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 5, 2009

Study Start

September 1, 1996

Primary Completion

May 1, 1997

Study Completion

September 1, 1997

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations

FR(1)