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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

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date March 9, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02139098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Dosing Regimens in the Pharmacotherapy of Insomnia
Official Title  ICMJE Phase III Study on Alternative Dosing Regimens in the Pharmacotherapy of Mild to Moderate Insomnia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: Amitriptyline
    50 mg capsule amitriptyline 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
  • Drug: Amitriptyline
    50 mg capsule amitriptyline before going to bed on 13 out of 17 nights
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Amitriptyline flexible dosing
    50 mg capsule amitriptyline before going to bed on 8 out of 17 nights/placebo
    Interventions:
    • Drug: Amitriptyline
    • Drug: Placebo
  • Experimental: Zolpidem flexible dosing
    5 mg capsule zolpidem before going to bed on 8 out of 17 nights/placebo
    Interventions:
    • Drug: Zolpidem
    • Drug: Placebo
  • Active Comparator: Amitriptyline fixed dosing
    50 mg capsule amitriptyline before going to bed on 8 out of 17 nights
    Intervention: Drug: Amitriptyline
  • Active Comparator: Zolpidem fixed dosing
    5 mg capsule zolpidem before going to bed on 8 out of 17 nights
    Intervention: Drug: Zolpidem
  • Active Comparator: Amitriptyline continuous dosing
    50 mg capsule amitriptyline before going to bed on 13 out of 17 nights
    Intervention: Drug: Amitriptyline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 7, 2018)
23
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
150
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139098
Other Study ID Numbers  ICMJE FOR1328-SP8
2013-003229-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Winfried Rief, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE
  • Johannes Gutenberg University Mainz
  • Philipps University Marburg Coordination Centre for Clinical Trials
Investigators  ICMJE
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
PRS Account Philipps University Marburg Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP