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Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
trazodone, pregabalin
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, trazodone, pregabalin, Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Inventory (PSQI), Brief Pain Inventory (BPI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria
  • written, informed consent
  • able to understand and comply with the requirements of the study

Exclusion Criteria:

  • pregnancy or breastfeeding
  • unwillingness to discontinue other prescribed medications before entering in the study
  • patients who had previously received trazodone without improvement or who did not tolerate the drug
  • patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)

Sites / Locations

  • Instituto de Neurociencias

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm study

Arm Description

Outcomes

Primary Outcome Measures

Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire

Secondary Outcome Measures

Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression Scale
Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events

Full Information

First Posted
November 12, 2008
Last Updated
December 1, 2014
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT00791739
Brief Title
Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
Official Title
Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, trazodone, pregabalin, Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Inventory (PSQI), Brief Pain Inventory (BPI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one arm study
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
trazodone, pregabalin
Other Intervention Name(s)
Deprax, Lyrica
Intervention Description
phase I (from baseline to week 12): trazodone, in a starting dose of 50 mg at bedtime subsequently adjusted according to drug's efficacy and tolerability phase II (from week 12 to week 24): addition of pregabalin in a starting dose of 75 mg/day subsequently adjusted according to drug's efficacy and tolerability
Primary Outcome Measure Information:
Title
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
Time Frame
Baseline, 6, 12, 18 and 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression Scale
Time Frame
Baseline, 6, 12, 18, and 24 weeks
Title
Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events
Time Frame
baseline, 6, 12, 18, and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria written, informed consent able to understand and comply with the requirements of the study Exclusion Criteria: pregnancy or breastfeeding unwillingness to discontinue other prescribed medications before entering in the study patients who had previously received trazodone without improvement or who did not tolerate the drug patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena P Calandre, MD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Neurociencias
City
Granada
ZIP/Postal Code
18012
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20831796
Citation
Morillas-Arques P, Rodriguez-Lopez CM, Molina-Barea R, Rico-Villademoros F, Calandre EP. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study. BMC Musculoskelet Disord. 2010 Sep 10;11:204. doi: 10.1186/1471-2474-11-204.
Results Reference
result
PubMed Identifier
21575194
Citation
Calandre EP, Morillas-Arques P, Molina-Barea R, Rodriguez-Lopez CM, Rico-Villademoros F. Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study. BMC Musculoskelet Disord. 2011 May 16;12:95. doi: 10.1186/1471-2474-12-95.
Results Reference
derived
Links:
URL
http://www.ugr.es/~ineurociencias/ie/inicio.php
Description
Web page of the Institute of Neuroscience of the University of Granada

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Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

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