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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
Sponsor:
Collaborators:
Johannes Gutenberg University Mainz
Philipps University Marburg Coordination Centre for Clinical Trials
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center

Study Description
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Brief Summary:
The purpose of this study is to evaluate whether drug efficiency of zolpidem and amitriptyline can be conditioned according to learning theory in patients with primary insomnia.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Amitriptyline Drug: Zolpidem Drug: Placebo Phase 3

Detailed Description:
Previous research has shown that repeated drug treatments can be regarded as conditioning processes. Sleep disorders are especially of interest to be investigated under the perspective of conditioning with drugs, since sleep quality can be defined both in terms of subjective ratings (self-rated sleep quality parameters) and objective measures (via polysomnographic assessment PSG; e.g., total sleep time, sleep onset, sleep architecture). By using two different drugs (zolpidem, amitriptyline) that modulate sleep differentially, the investigators intend to implement a conditioning paradigm in sleep disorders dissociating conditioning effects on subjective and objective sleep parameters. Both drugs should affect objective and subjective sleep parameters positively, while only amitriptyline should modulate the objectively assessed sleep architecture by REM-suppression (latency of REM-sleep onset, percentage of REM-sleep).Patients with mild to moderate insomnia will undergo a classical conditioning paradigm with one of two study medications: amitriptyline or zolpidem. After an acquisition period and a wash-out period, conditioned sleep changes are assessed in an evocation trial. During a second treatment phase of 7 days, patients receive different doses of amitriptyline (between 0mg and 50mg per night) or zolpidem (between 0mg and 5mg per night) to evaluate alternative dosing regimens in the pharmacotherapy of mild to moderate Insomnia.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Amitriptyline flexible dosing
50 mg capsule amitriptyline before going to bed on 8 out of 17 nights/placebo
 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
 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
 Drug: Amitriptyline
50 mg capsule amitriptyline before going to bed on 13 out of 17 nights


Outcome Measures
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Primary Outcome Measures :
  1. Objective Total Sleep Time [ Time Frame: Change from baseline to day 10 after first medication intake ]
    assessed by polysomnography

  2. Objective Sleep Onset Latency [ Time Frame: Change from baseline to day 10 after first medication intake ]
    assessed by polysomnography

  3. Self-reported Total Sleep Time [ Time Frame: Change from baseline to day 10 after first medication intake ]
    assessed by sleep diary

  4. Self-Reported Sleep Onset Latency [ Time Frame: Change from baseline to day 10 after first medication intake ]
    assessed by sleep diary


Secondary Outcome Measures :
  1. Percentage of REM sleep [ Time Frame: Change from baseline to day 10 after first medication intake ]
    assessed by polysomnography

  2. REM onset latency [ Time Frame: Change from baseline to day 10 after first medication intake ]
    assessed by polysomnography

  3. Objective Sleep Efficiency [ Time Frame: Change from baseline to day 17 after first medication intake ]
    assessed by actigraphy

  4. Objective Total Sleep Time [ Time Frame: Change from baseline to day 17 after first medication intake ]
    assessed by actigraphy

  5. Self-Reported Total Sleep Time [ Time Frame: Change from baseline to day 18 after first medication intake ]
    assessed by sleep diary

  6. Self-reported Sleep Onset Latency (min) [ Time Frame: Change from baseline to day 18 after first medication intake ]
    assessed by sleep diary

  7. Self-reported Sleep Onset Latency (evaluation) [ Time Frame: Change from baseline to day 18 after first medication intake ]
    assessed by sleep diary


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. age between 18 years to 69 years
  2. fluent in German language
  3. provide written informed consent
  4. ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion Criteria:

  1. Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)

  2. 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
  3. Allergies to ingredients of placebo or novel-tasting drink (CS)
  4. currently pregnant (verified by urine pregnancy test) or lactating
  5. patients scoring ≥12 on the Epworth Sleepiness Scale
  6. patients scoring below 8 or above 21 on the Insomnia Severity Index
  7. 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)
  8. nicotine consumption > 10 cigarettes/day
  9. unwillingness to refrain from alcohol consumption throughout the study
  10. 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)
  11. change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization
  12. intake of psychotropic medication during the last 3 months
  13. participation in any other clinical trial 3 months prior to visit 1
  14. women of childbearing age not using 2 highly effective contraceptive methods
  15. employee of the Sponsor or the principal investigator
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg
Marburg, Hessen, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
Johannes Gutenberg University Mainz
Philipps University Marburg Coordination Centre for Clinical Trials
Investigators
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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
More Information
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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
Keywords provided by Winfried Rief, Philipps University Marburg Medical Center:
sleep architecture
conditioning of pharmacological responses
insomnia
Additional relevant MeSH terms:
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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