Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

NCT00791739 | Completed Phase 4

• 1 other identifier: TZD-PGB-2008
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; trazodone; pregabalin; Fibromyalgia Impact Questionnaire (FIQ); Pittsburgh Sleep Quality Inventory (PSQI); Brief Pain Inventory (BPI)

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 6, 12, 18 and 24 weeks

Secondary Outcomes (2)

• 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

  Baseline, 6, 12, 18, and 24 weeks

• Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events

  baseline, 6, 12, 18, and 24 weeks

Study Arms (1)

one arm study

EXPERIMENTAL

Drug: trazodone, pregabalin

Interventions

trazodone, pregabalin DRUG

* 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

Also known as: Deprax, Lyrica

one arm study

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Instituto de Neurociencias

Granada, Granada, 18012, Spain

Location

Related Publications (2)

• 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.

  PMID: 20831796 RESULT

• 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.

  PMID: 21575194 DERIVED

Related Links

• Web page of the Institute of Neuroscience of the University of Granada

MeSH Terms

Conditions

Fibromyalgia

Interventions

Trazodone; Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Elena P Calandre, MD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

ES (1)