CompletedPhase 4

The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia

Japan17 participantsStarted 2018-02-06

Plain-language summary

To investigate effects on combination use of Ramelteon in the dose reduction or interruption process of (non-)BZD hypnotics during the dose reduction or interruption algorithm.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Patients diagnosed as chronic insomnia having sleep onset disturbance, and with a duration of the disease of at least 6 months
✓. Patients diagnosed with chronic insomnia comorbid with mood disorders (depression or bipolar disorder) can be included to this study if they have remission of mood symptoms.
✓. Patients taking (non-)BZD hypnotics (including etizolam at bedtime) at a fixed dose in the following patterns since at least 1 month prior to consent (over 90% of drug compliance should be confirmed at the time of medical interview):

What they're measuring

The achievement ratio of the 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12weeks or withdrawal without any deterioration of insomnia symptoms.

Timeframe: 12 weeks

The rate of subjects who achieved more than 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12 weeks or withdrawal since informed consent.

Timeframe: 12 weeks

Trial details

NCT IDNCT03461042

SponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

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