Clinical Trials Logo

Clinical Trial Summary

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).


Clinical Trial Description

Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00631657
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date March 4, 2008
Completion date November 19, 2009

See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT06012149 - Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Active, not recruiting NCT02836080 - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT) N/A
Active, not recruiting NCT02907658 - Efficacy of Internet Use Disorder Prevention N/A
Completed NCT02710344 - Using Telehealth to Improve Psychiatric Symptom Management N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Active, not recruiting NCT02761733 - The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers N/A
Completed NCT01947283 - Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation N/A
Completed NCT01690013 - Life Quality and Health in Patients With Klinefelter Syndrome N/A
Completed NCT01633138 - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy N/A
Completed NCT01656707 - Adaptive Treatment for Adolescent Cannabis Use Disorders N/A
Completed NCT01415323 - Agitation in the Acute Psychiatric Department
Completed NCT01701765 - Outcomes and Discharge of Long-stay Psychiatric Patients N/A
Completed NCT00375167 - Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery N/A
Terminated NCT00757497 - Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia Phase 1
Terminated NCT03527550 - Cognitive Control Training for Urgency in a Naturalistic Clinical Setting N/A
Withdrawn NCT03518996 - Non-Invasive Brain Stimulation and Delirium N/A