13 terminated. 13 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Terminated 13 |
Follow Sleep Initiation and Maintenance Disorders: new trials by email Literature Review of Sleep Initiation and Maintenance Disorders trials Research Report on Sleep Initiation and Maintenance Disorders
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia SAGE-217, Placebo - Major Depressive Disorder, Insomnia | Phase 3 | Terminated | Biogen | 87 | 2019-02-04 | 2023-11-29 |
| Alternative Dosing Regimens in the Pharmacotherapy of Insomnia Amitriptyline, Zolpidem, Placebo - Insomnia | Phase 3 | Terminated | Philipps University Marburg | 23 | 2014-05-01 | 2018-03-09 |
| Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties Volinanserin (M100907), Lormetazepam - Sleep Initiation and Maintenance Disorders | Phase 3 | Terminated | Sanofi | 33 | 2008-11-01 | 2009-08-28 |
| Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007) esmirtazapine - Sleep Initiation and Maintenance Disorders, Mental Disorders | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 184 | 2008-10-07 | 2021-02-02 |
| Ramelteon for Insomnia Comorbid With Asthma Ramelteon - Insomnia, Asthma | Phase 3 | Terminated | Northwestern University | 2 | 2008-03-01 | 2013-05-01 |
| Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance Ramelteon, Placebo - Insomnia, Bipolar Disorder | Phase 3 | Terminated | Lindner Center of HOPE | 21 | 2007-12-01 | 2013-05-10 |
| Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon Escitalopram, Ramelteon, Placebo - Major Depressive Disorder, Insomnia | Phase 3 | Terminated | University of Texas Southwestern Medical Center | 29 | 2007-05-01 | 2019-07-26 |
| Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus Volinanserin, Placebo - Sleep Initiation and Maintenance Disorders | Phase 3 | Terminated | Sanofi | 1847 | 2007-04-01 | 2016-05-26 |
| Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED) MK0928 / Duration of Treatment : 8 Weeks - Primary Insomnia | Phase 3 | Terminated | H. Lundbeck A/S | 138 | 2006-09-01 | 2015-01-14 |
| Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression Indiplon, Sertraline - Insomnia, Depression | Phase 3 | Terminated | Neurocrine Biosciences | 380 | 2005-11-01 | 2007-10-02 |
| Efficacy of Ramelteon in Adults With Chronic Insomnia Ramelteon, Placebo - Chronic Insomnia | Phase 3 | Terminated | Takeda | 1081 | 2005-02-01 | 2012-02-28 |
| Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED) MK0928, gaboxadol / Duration of Treatment - 6 weeks, Comparator: placebo / Duration of Treatment - 6 weeks - Primary Insomnia | Phase 3 | Terminated | H. Lundbeck A/S | 465 | 2004-11-01 | 2015-01-14 |
| Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia Eschscholtzia Californica, Eschscholtzia Californica Placebo - Sleep Initiation and Maintenance Disorders | Phase 3 | Terminated | Boehringer Ingelheim | 49 | 1998-01-01 | 2014-07-08 |
Parasomnias (3) · Depression (2) · Depressive Disorder, Major (2) · Sleep Wake Disorders (2) · Asthma (1) · Bipolar Disorder (1) · Dyssomnias (1) · Mental Disorders (1) · Sleep Disorders, Intrinsic (1)
Nervous System Diseases (13) · Dyssomnias (12) · Mental Disorders (12) · Sleep Disorders, Intrinsic (12) · Sleep Wake Disorders (11) · Mood Disorders (3) · Behavior (2) · Behavioral Symptoms (2) · Depressive Disorder (2) · Neurologic Manifestations (2) · Pathological Conditions, Signs and Symptoms (2) · Signs and Symptoms (2) · Bipolar and Related Disorders (1) · Bronchial Diseases (1) · Hypersensitivity (1)
ramelteon (4) · Duration of Therapy (2) · volinanserin (2) · Amitriptyline (1) · Escitalopram (1) · Mirtazapine (1) · Sertraline (1) · Zolpidem (1) · gaboxadol (1) · indiplon (1) · lormetazepam (1) · zuranolone (1)
H. Lundbeck A/S (2) · Sanofi (2) · Biogen (1) · Boehringer Ingelheim (1) · Lindner Center of HOPE (1) · Merck Sharp & Dohme LLC (1) · Neurocrine Biosciences (1) · Northwestern University (1) · Philipps University Marburg (1) · Takeda (1) · University of Texas Southwestern Medical Center (1)
United States (6) · Germany (2) · Spain (2) · Argentina (1) · Australia (1) · Austria (1) · Belgium (1) · Brazil (1) · Canada (1) · Chile (1) · Colombia (1) · Czechia (1) · France (1) · Hong Kong (1) · India (1)
Bettina K Doering, Dr. (1) · Brandon S Lu, MD, MS (1) · Carmen Schade-Brittinger (1) · Susan L McElroy, MD (1) · Winfried Rief, Prof. Dr. (1)