The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy

NCT02669082 | Completed Phase 4 Results

• 3 other identifiers: Ramelteon-4002JapicCTI-163143U1111-1177-4116
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.

Conditions

Insomnia; Major Depressive Disorder

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period

  Sleep latency was defined as time period measured from "lights out," or bedtime, to the beginning of sleep. Sleep latency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days was evaluated. A negative change from Baseline indicates improvement.

  Baseline and the end of the Treatment Period (up to Week 8)

Secondary Outcomes (8)

• Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period

  Baseline and the end of the Treatment Period (up to Week 8)

• Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period

  Baseline and the end of the Treatment Period (up to Week 8)

• Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period

  Baseline and the end of the Treatment Period (up to Week 8)

• Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period

  Baseline and the end of the Treatment Period (up to Week 8)

• Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period

  Baseline and the end of the Treatment Period (up to Week 8)

Study Arms (1)

Ramelteon 8 mg

EXPERIMENTAL

Ramelteon 8 mg, tablet, orally, once daily at bedtime for 8 weeks.

Drug: Ramelteon

Interventions

Ramelteon DRUG

Ramelteon tablets

Also known as: Rozerem, TAK-375

Ramelteon 8 mg

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has difficulty in initiating sleep at least 3 days per week for at least 4 weeks at the time of informed consent.
• Has Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)-defined depression.
• Man or woman between 20 and 64 years of age, inclusive, at the time of informed consent.
• Outpatient.
• Meets either of the following criteria based on the 17-item Hamilton Rating Scale for Depression (HAM-D17) both at the start of the run-in period and the start of the study treatment period: has a score of 2 for "6: Insomnia Early", or has a score of 1 for "6: Insomnia Early" AND a score of at least 3 in total for "7: Insomnia Middle" and "8: Insomnia Late".
• Has a total HAM-D17 score of 16 or under both at the start of the run-in period and the start of the study treatment period.
• Under treatment of the same antidepressant agents on a stable dose for at least 4 weeks before the start of the run-in period.
• Goes to bed routinely in a daily life (time for bed between 21.00 p.m. and 1.00 a.m. at least 4 days per week).
• Actigraphy shows at least 3 days with sleep latency 30 minutes or longer AND total nocturnal sleep time 6.5 hours or shorter on the same day during the run-in period.
• In the opinion of the principal investigator or investigator, is capable of understanding the contents of the study and complying with study requirements.
• Is capable of signing and dating the informed consent form in person before any study procedures.

You may not qualify if:

• Has a history of hypersensitivity to ramelteon and melatonin.
• Has severe liver disorder.
• Took ramelteon within 4 weeks before the informed consent.
• Using any insomnia medications (including investigational drugs and unapproved drugs) for 2 weeks before the treatment period.
• Shift worker or night worker.
• Has complications of psychiatric or neurological diseases that affect sleep state other than depression.
• Has a HAM-D17 score of at least 1 for"11: Suicide" at the start of the run-in period or the start of the study treatment period, or any suicide attempts within 24 weeks before or during the run-in period.
• Pregnant woman, nursing mother, or woman who plans to become pregnant or donate eggs before the informed consent, during the study period or within 4 weeks after the end of the study.
• Is participating in any other investigational or post-marketing clinical trial/study.
• For other reason, judged not appropriate for participation in this study by the principal investigator or investigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

You Ariyoshi Sleep Clinic

Kitakyushu, Fukuoka, Japan

Location

Ishikawa Mental Clinic

Sapporo, Hokkaido, Japan

Location

Minami 1jo Mental Clinic

Sapporo, Hokkaido, Japan

Location

Senzoku Psychosomatic Clinic

Meguro City, Tokyo, Japan

Location

Sangenjaya Neurology and Psychosomatic Clinic

Setagaya City, Tokyo, Japan

Location

Himorogi Kokorono Clinic

Shinjuku, Tokyo, Japan

Location

Seiwa Hospital

Shinjuku, Tokyo, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: May 9, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (7)