Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

NCT02139098 | Terminated Phase 3 DMC

• 2 other identifiers: FOR1328-SP82013-003229-27
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

sleep architecture; conditioning of pharmacological responses; insomnia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• Percentage of REM sleep

  Change from baseline to day 10 after first medication intake

• REM onset latency

  Change from baseline to day 10 after first medication intake

• Objective Sleep Efficiency

  Change from baseline to day 17 after first medication intake

• Objective Total Sleep Time

  Change from baseline to day 17 after first medication intake

• Self-Reported Total Sleep Time

  Change from baseline to day 18 after first medication intake

Study Arms (5)

Amitriptyline flexible dosing

EXPERIMENTAL

50 mg capsule amitriptyline before going to bed on 8 out of 17 nights/placebo

Drug: Amitriptyline; Drug: Placebo

Zolpidem flexible dosing

EXPERIMENTAL

5 mg capsule zolpidem before going to bed on 8 out of 17 nights/placebo

Drug: Zolpidem; Drug: Placebo

Amitriptyline fixed dosing

ACTIVE COMPARATOR

50 mg capsule amitriptyline before going to bed on 8 out of 17 nights

Drug: Amitriptyline

Zolpidem fixed dosing

ACTIVE COMPARATOR

5 mg capsule zolpidem before going to bed on 8 out of 17 nights

Drug: Zolpidem

Amitriptyline continuous dosing

ACTIVE COMPARATOR

50 mg capsule amitriptyline before going to bed on 13 out of 17 nights

Drug: Amitriptyline

Interventions

Amitriptyline DRUG

50 mg capsule amitriptyline before going to bed on 8 out of 17 nights

Amitriptyline fixed dosing; Amitriptyline flexible dosing

Zolpidem DRUG

5 mg capsule zolpidem before going to bed on 8 out of 17 nights

Zolpidem fixed dosing; Zolpidem flexible dosing

Placebo DRUG

Placebo

Amitriptyline flexible dosing; Zolpidem flexible dosing

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Johannes Gutenberg University Mainz: collaborator
• Philipps University Marburg Coordination Centre for Clinical Trials: collaborator

Study Sites (1)

Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Amitriptyline; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

DE (1)