Alternative Dosing Regimens in the Pharmacotherapy of Insomnia (ALPHASOM)
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ClinicalTrials.gov Identifier: NCT02139098 |
Recruitment Status :
Terminated
(Recruiting problems because of the time expenditure required for participating and the strict criteria of inclusion and exclusion)
First Posted : May 15, 2014
Last Update Posted : March 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Insomnia | Drug: Amitriptyline Drug: Zolpidem Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase III Study on Alternative Dosing Regimens in the Pharmacotherapy of Mild to Moderate Insomnia |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Amitriptyline flexible dosing
50 mg capsule amitriptyline before going to bed on 8 out of 17 nights/placebo
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Drug: Amitriptyline
50 mg capsule amitriptyline before going to bed on 8 out of 17 nights Drug: Placebo Placebo |
Experimental: Zolpidem flexible dosing
5 mg capsule zolpidem before going to bed on 8 out of 17 nights/placebo
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Drug: Zolpidem
5 mg capsule zolpidem before going to bed on 8 out of 17 nights Drug: Placebo Placebo |
Active Comparator: Amitriptyline fixed dosing
50 mg capsule amitriptyline before going to bed on 8 out of 17 nights
|
Drug: Amitriptyline
50 mg capsule amitriptyline before going to bed on 8 out of 17 nights |
Active Comparator: Zolpidem fixed dosing
5 mg capsule zolpidem before going to bed on 8 out of 17 nights
|
Drug: Zolpidem
5 mg capsule zolpidem before going to bed on 8 out of 17 nights |
Active Comparator: Amitriptyline continuous dosing
50 mg capsule amitriptyline before going to bed on 13 out of 17 nights
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Drug: Amitriptyline
50 mg capsule amitriptyline before going to bed on 13 out of 17 nights |
- Objective Total Sleep Time [ Time Frame: Change from baseline to day 10 after first medication intake ]assessed by polysomnography
- Objective Sleep Onset Latency [ Time Frame: Change from baseline to day 10 after first medication intake ]assessed by polysomnography
- Self-reported Total Sleep Time [ Time Frame: Change from baseline to day 10 after first medication intake ]assessed by sleep diary
- Self-Reported Sleep Onset Latency [ Time Frame: Change from baseline to day 10 after first medication intake ]assessed by sleep diary
- Percentage of REM sleep [ Time Frame: Change from baseline to day 10 after first medication intake ]assessed by polysomnography
- REM onset latency [ Time Frame: Change from baseline to day 10 after first medication intake ]assessed by polysomnography
- Objective Sleep Efficiency [ Time Frame: Change from baseline to day 17 after first medication intake ]assessed by actigraphy
- Objective Total Sleep Time [ Time Frame: Change from baseline to day 17 after first medication intake ]assessed by actigraphy
- Self-Reported Total Sleep Time [ Time Frame: Change from baseline to day 18 after first medication intake ]assessed by sleep diary
- Self-reported Sleep Onset Latency (min) [ Time Frame: Change from baseline to day 18 after first medication intake ]assessed by sleep diary
- Self-reported Sleep Onset Latency (evaluation) [ Time Frame: Change from baseline to day 18 after first medication intake ]assessed by sleep diary

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age between 18 years to 69 years
- fluent in German language
- provide written informed consent
- ability to understand the explanations and instructions given by the study physician and the investigator
Exclusion Criteria:
- Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)
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Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC; Fachinformation in Germany) assessed by physical examination (including ECG) and medical history
- allergies to amitriptyline hydrochloride or any of its ingredients
- allergies to zolpidem or any of its ingredients
- acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug
- urinary retention
- delirium
- untreated closed-angle glaucoma
- prostatic hyperplasia
- pyloric stenosis
- paralytic ilius
- suicidal thoughts
- liver/ kidney/ pulmonary insufficiency
- myasthenia gravis
- hypokalemia
- bradycardia
- coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders
- increased risk of seizures/ history of seizures
- substance dependence syndrome/ history of substance dependence syndrome
- Allergies to ingredients of placebo or novel-tasting drink (CS)
- currently pregnant (verified by urine pregnancy test) or lactating
- patients scoring ≥12 on the Epworth Sleepiness Scale
- patients scoring below 8 or above 21 on the Insomnia Severity Index
- patients suffering from a mental disorder as verified by the SCID (major depression; psychosis; brain injury; substance abuse or dependency syndrome during the last 6 months before V1)
- nicotine consumption > 10 cigarettes/day
- unwillingness to refrain from alcohol consumption throughout the study
- Concomitant medication interfering with study medication intake due to potential interactions (all psychotropic medication including analgetics and muscle relaxants, hypericum derivatives; antihypertensives; anti-arrhythmic agents; antibiotics; cisaprid; anti-malaria drugs; diuretics; imidazole antifungals; cumarin derivatives; antihistaminics; calcium channel blockers; medications that enlarge the QT interval or may lead to hypokalemia)
- change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization
- intake of psychotropic medication during the last 3 months
- participation in any other clinical trial 3 months prior to visit 1
- women of childbearing age not using 2 highly effective contraceptive methods
- employee of the Sponsor or the principal investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139098
Germany | |
Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg | |
Marburg, Hessen, Germany, 35032 |
Principal Investigator: | Winfried Rief, Prof. Dr. | Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg | |
Principal Investigator: | Bettina K Doering, Dr. | Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg | |
Study Chair: | Carmen Schade-Brittinger | Koordinierungszentrum für Klinische Studien Marburg, Philipps University Marburg |
Responsible Party: | Winfried Rief, Professor Dr., Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT02139098 |
Other Study ID Numbers: |
FOR1328-SP8 2013-003229-27 ( EudraCT Number ) |
First Posted: | May 15, 2014 Key Record Dates |
Last Update Posted: | March 9, 2018 |
Last Verified: | March 2018 |
sleep architecture conditioning of pharmacological responses insomnia |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Amitriptyline Zolpidem Amitriptyline, perphenazine drug combination Sleep Aids, Pharmaceutical Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs GABA-A Receptor Agonists GABA Agonists |
GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents Antipsychotic Agents |