FibromyalgiaPhase 4NCT00766350
Comparative Efficacy and Tolerability of Quetiapine XR and Amitriptyline in the Treatment of Fibromyalgia
A Phase 4 study testing amitriptyline and quetiapine in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial summary
Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of the present study is to compare, in a controlled setting, the efficacy and the tolerability of quetiapine extended release with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- amitriptyline and quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 70 years.
- Meeting American College of Rheumatology criteria for primary fibromyalgia: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination.
- A FIQ total score (0 100) of 40 or greater
- A score of 4 or greater on the average pain item of the BPI
- Written informed consent
- Female patients of childbearing potential must be using a reliable contraceptive method and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
- Able to understand and comply with the requirements of the study.
Who cannot join
- Evidence of current traumatic injury, inflammatory rheumatic disease, or infectious or endocrine related joint disease.
- A lifetime history of hypomania, mania, psychosis or dementia.
- Current primary Axis I diagnosis other than major depressive disorder
- Substance or alcohol dependence at enrolment and within the past 12 months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM IV
- Severe depression as evidenced by a Beck Depression Inventory score ≥ 30
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
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- History of seizures
- Known lack of response to 2, or more than 2, different type of antidepressants in depression of fibromyalgia.
- Pregnancy or breast feeding.
- Patients with a history of urinary retention, angle closure glaucoma, or increased intraocular pressure.
- Patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or conditions which would predispose patients to severe hypotension (dehydration, hypovolemia and treatment with antihypertensive medications).
- Patients who have received IMAOs, SSRIs or other antidepressants within two weeks of randomization.
- Current or past history of kidney or liver insufficiency
- Prior to randomization. Unwillingness to discontinue previously prescribed drugs for fibromyalgia other than those authorized in the protocol, as acetaminophen and bromazepam
- Patients who have received quetiapine or amitriptyline within 1 year of randomization.
- Patients with known intolerance or lack of response to quetiapine fumarate and/or amitriptyline, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors within 14 days of enrolment, including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir
- Use of any of the following cytochrome P450 inducers within 14 days of enrolment, including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's wort, and glucocorticoids
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM IV criteria within 4 weeks of enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment, with clinical relevance.
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension), as judged by the investigator
- Involvement in planning and conduct of the study
- Previous enrolments or randomisation of treatment in the present study.
- Participation in another trial with drugs within 4 weeks of enrolment into this study or a longer period in accordance with local requirements.
- Patients with uncontrolled Diabetes Mellitus (DM)
- An absolute neutrophil count (ANC) equal or lower than 1.5 x 109 per liter.
- Patients who show at the randomization visit a reduction in the FIQ total score equal or greater than 20% from the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Pilot Clinical Trial to Assess the Comparative Efficacy and Tolerability of Quetiapine XR Versus Amitriptyline for the Treatment of Patients With Fibromyalgia
Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of the present study is to compare, in a controlled setting, the efficacy and the tolerability of quetiapine extended release with amitriptyline in the treatment of patients with fibromyalgia
- Conditions
- Fibromyalgia
- Being tested
- amitriptyline, quetiapine
- Keywords
- fibromyalgia, quetiapine, amitriptyline
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amitriptylineDrug
Also called Tryptizol
initial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks
quetiapineDrug
Also called Seroquel XR
initial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| amitriptyline | Active comparator | Not described Receives: Drug: amitriptyline |
| quetiapine | Experimental | Not described Receives: Drug: quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to endpoint in the total score of Fibromyalgia Impact Questionnaire
Measured: baseline, 4, 8, 12 and 16 weeks
Secondary outcomes (2)
Change from baseline to endpoint in the scores of the Brief Pain Inventory, the Pittsburgh Sleep Quality Inventory, the Beck Depression Inventory, and the State and Trait Anxiety Inventory
Measured: baseline, 4, 8, 12 and 16 weeks
Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing adverse events, proportion of patients experiencing serious adverse events, adverse events description and classification.
Measured: baseline, 0, 4, 8, 12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Hospital Clinico Universitario San Cecilio
- Responsible party
- Principal investigator, Elena Pita Calandre, Universidad de Granada
- Investigators
- Elena P Calandre, MD, Principal investigator, Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766350
- Sponsor's protocol ID
- D1443C00024
- Status last verified
- Dec 2014
- First submitted
- 1 Oct 2008
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hidalgo J, Rico-Villademoros F, Calandre EP. An open-label study of quetiapine in the treatment of fibromyalgia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):71-7. doi: 10.1016/j.pnpbp.2006.06.023. Epub 2006 Aug 4.
PubMed 16889882
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Clinical Trial to Assess the Comparative Efficacy and Tolerability of Quetiapine XR Versus Amitriptyline for the Treatment of Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00766350
- Acronym / sponsor ID
- D1443C00024
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, quetiapine, amitriptyline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- AstraZeneca, Hospital Clinico Universitario San Cecilio
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quetiapine, a second generation antipsychotic, has shown beneficial activity on fibromyalgia symptomatology, administered as add-on treatment, in a sample of 35 patients. The purpose of the present study is to compare, in a controlled setting, the efficacy and the tolerability of quetiapine extended release with amitriptyline in the treatment of patients with fibromyalgia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amitriptyline | Active comparator | Drug: amitriptyline |
| quetiapine | Experimental | Drug: quetiapine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged 18 70 years.
- Meeting American College of Rheumatology criteria for primary fibromyalgia: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination.
- A FIQ total score (0 100) of 40 or greater
- A score of 4 or greater on the average pain item of the BPI
- Written informed consent
Key exclusion criteria (27 listed)
- Evidence of current traumatic injury, inflammatory rheumatic disease, or infectious or endocrine related joint disease.
- A lifetime history of hypomania, mania, psychosis or dementia.
- Current primary Axis I diagnosis other than major depressive disorder
- Substance or alcohol dependence at enrolment and within the past 12 months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM IV
- Severe depression as evidenced by a Beck Depression Inventory score ≥ 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amitriptylineAlso: Tryptizolinitial dose 10 mg/day, target dose: 25 mg/day, maximum dose: 75 mg/day, dosage form: tablets, duration: 16 weeks | Drug | amitriptyline |
| quetiapineAlso: Seroquel XRinitial dose: 50 mg/day, target dose: 100 mg/day, maximum dose: 300 mg/day, dosage form:extended release tablets , duration: 16 weeks | Drug | quetiapine |
Primary outcome
Mean change from baseline to endpoint in the total score of Fibromyalgia Impact Questionnaire
Time frame: baseline, 4, 8, 12 and 16 weeks
2 secondary outcomes
Change from baseline to endpoint in the scores of the Brief Pain Inventory, the Pittsburgh Sleep Quality Inventory, the Beck Depression Inventory, and the State and Trait Anxiety Inventory
Time frame: baseline, 4, 8, 12 and 16 weeks
Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing adverse events, proportion of patients experiencing serious adverse events, adverse events description and classification.
Time frame: baseline, 0, 4, 8, 12 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 16889882Hidalgo J, Rico-Villademoros F, Calandre EP. An open-label study of quetiapine in the treatment of fibromyalgia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):71-7. doi: 10.1016/j.pnpbp.2006.06.023. Epub 2006 Aug 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena P Calandre, MD principal investigator
Clinical Pharmacology Department of the Hospital Clinico Universitario San Cecilio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amitriptyline and quetiapine in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline to endpoint in the total score of Fibromyalgia Impact Questionnaire (time frame: baseline, 4, 8, 12 and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00766350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.