Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)

NCT00561821 | Completed Phase 3 Results

• 3 other identifiers: P0570921108MK-8265-006
• Study Type: interventional
• Target: 538
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants 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).

Conditions

Insomnia; Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders

Keywords

elderly; randomized; placebo controlled

Outcome Measures

Primary Outcomes (1)

• Average Wake Time After Sleep Onset Measured by Polysomnography

  Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.

  Up to Day 16

Secondary Outcomes (16)

• Average Latency to Persistent Sleep Measured by Polysomnography

  Up to Day 16

• Average Total Sleep Time Measured by Polysomnography

  Up to Day 16

• Average Number of Awakenings Measured by Polysomnography

  Up to Day 16

• Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography

  Up to Day 16

• Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography

  Up to Day 16

Study Arms (4)

Esmirtazapine 0.5 mg

EXPERIMENTAL

one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days

Drug: Esmirtazapine; Drug: Placebo

Esmirtazapine 1.5 mg

EXPERIMENTAL

one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days

Drug: Esmirtazapine; Drug: Placebo

Esmirtazapine 3.0 mg

EXPERIMENTAL

one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days

Drug: Esmirtazapine; Drug: Placebo

Placebo

PLACEBO COMPARATOR

one placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days

Drug: Placebo

Interventions

Esmirtazapine DRUG

one tablet daily

Esmirtazapine 0.5 mg; Esmirtazapine 1.5 mg; Esmirtazapine 3.0 mg

Placebo DRUG

one tablet daily

Esmirtazapine 0.5 mg; Esmirtazapine 1.5 mg; Esmirtazapine 3.0 mg; Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• questionnaires;
• 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 hours and 2400 hours, with no more variation

You may not qualify if:

• have other sleep disorders (DSM-IV-TR), such as sleep
• related breathing disorders Apnea-Hypopnea Index (AHI) greater than or equal
• to 15), Periodic Leg Movements with Arousals Index (PLMAI)
• greater than or equal to 10), restless leg syndrome,
• narcolepsy, circadian sleep wake rhythm disorders,
• Rapid Eye Movement (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 Major Depressive Disorder (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
• on the Mini-Mental State Examination;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Wake Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: November 20, 2007
• Primary Completion: December 21, 2009
• Study Completion: December 21, 2009
• Last Updated: October 3, 2018
• Results First Posted: August 5, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share