A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder

Phase 3

• Conditions: Chronic Somatoform Pain Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12610000603011
• Lead Sponsor: Dr Peter Farnbach

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Provision of written and informed consent prior to initiating any study related procedures.
2. Male and female aged 18 to 65 years, inclusive.
3. Documented clinical diagnosis meeting criteria from the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) for 307.89 Chronic (Somatoform) Pain Disorder associated with both Psychological Factors and General Medical Condition.
4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hCG) pregnancy test at enrolment.
5. Patients who have been on stable doses of non-opioid analgesic/s, Non-steroidal anti-inflammatory drugs (NSAIDs) with/or without an antidepressant (excluding fluvoxamine), for at least 6 weeks.
6. Be able to understand and comply with the requirements of the study, as judged by the investigator.
7. Clinical diagnosis of one or more of the following spine structure problems: facet joints, spinal stenosis, paraspinal muscles, sacroiliac joint, spondylolysis/spondylolisthesis, nonspecific back pain and diskogenic.

Exclusion Criteria

1. Current or past history of: manic, hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR).
2. Presence or history of a clinically significant neurological disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington’s disease, epilepsy etc.).
3. Pregnancy or lactation.
4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
5. Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
7. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids .
8. Administration of a depot antipsychotic injection within two dosing interval before randomisation.
9. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria.
10. Medical conditions that would affect absorption, and metabolism, or excretion of study medication (e.g., malabsorption syndrome, liver disease).
11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
12. Involvement in the planning and conduct of the study.
13. Previous enrolment or randomisation of treatment in the present study.
14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
15. A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) > 8.5%;
Admitted to hospital for treatment of DM or DM related illness in past 12 weeks;
Not under physician care for DM;
Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled;
Physician responsible for patient’s DM care has not approved patient’s participation in the study;
Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks; and
Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
16. An absolute neutrophil count (ANC) of less than or equal to 1.5 x 109 per litre.

Study & Design

• Study Type: Interventional
• Study Design: Not specified