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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003229-27 | EudraCT Number |
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Recruiting problems because of the time expenditure required for participating and the strict criteria of inclusion and exclusion
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| Name | Class |
|---|---|
| Johannes Gutenberg University Mainz | OTHER |
| Philipps University Marburg Coordination Centre for Clinical Trials | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amitriptyline flexible dosing | Experimental | 50 mg capsule amitriptyline before going to bed on 8 out of 17 nights/placebo |
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| Zolpidem flexible dosing | Experimental | 5 mg capsule zolpidem before going to bed on 8 out of 17 nights/placebo |
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| Amitriptyline fixed dosing | Active Comparator | 50 mg capsule amitriptyline before going to bed on 8 out of 17 nights |
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| Zolpidem fixed dosing | Active Comparator | 5 mg capsule zolpidem before going to bed on 8 out of 17 nights |
|
| Amitriptyline continuous dosing | Active Comparator | 50 mg capsule amitriptyline before going to bed on 13 out of 17 nights |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amitriptyline | Drug | 50 mg capsule amitriptyline before going to bed on 8 out of 17 nights |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Total Sleep Time | assessed by polysomnography | Change from baseline to day 10 after first medication intake |
| Objective Sleep Onset Latency | assessed by polysomnography | Change from baseline to day 10 after first medication intake |
| Self-reported Total Sleep Time | assessed by sleep diary | Change from baseline to day 10 after first medication intake |
| Self-Reported Sleep Onset Latency | assessed by sleep diary | Change from baseline to day 10 after first medication intake |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of REM sleep | assessed by polysomnography | Change from baseline to day 10 after first medication intake |
| REM onset latency | assessed by polysomnography |
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Inclusion Criteria:
Exclusion Criteria:
Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)
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 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
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Carmen Schade-Brittinger | Koordinierungszentrum für Klinische Studien Marburg, Philipps University Marburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg | Marburg | Hesse | 35032 | Germany |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Zolpidem | Drug | 5 mg capsule zolpidem before going to bed on 8 out of 17 nights |
|
| Amitriptyline | Drug | 50 mg capsule amitriptyline before going to bed on 13 out of 17 nights |
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| Placebo | Drug | Placebo |
|
| Change from baseline to day 10 after first medication intake |
| Objective Sleep Efficiency | assessed by actigraphy | Change from baseline to day 17 after first medication intake |
| Objective Total Sleep Time | assessed by actigraphy | Change from baseline to day 17 after first medication intake |
| Self-Reported Total Sleep Time | assessed by sleep diary | Change from baseline to day 18 after first medication intake |
| Self-reported Sleep Onset Latency (min) | assessed by sleep diary | Change from baseline to day 18 after first medication intake |
| Self-reported Sleep Onset Latency (evaluation) | assessed by sleep diary | Change from baseline to day 18 after first medication intake |
| D001523 |
| Mental Disorders |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |