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Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

NCT02139098 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-03-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Philipps University Marburg Coordination Centre for Clinical Trials

    collaborator UNKNOWN

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Winfried Rief, Prof. Dr. · Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg

  • Bettina K Doering, Dr. · Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg

  • Carmen Schade-Brittinger · Koordinierungszentrum für Klinische Studien Marburg, Philipps University Marburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02139098 on ClinicalTrials.gov