Depression Mental and Behavioural Disorders Depression
Conditions
Interventions
The participants were recruited at the following two sites:
1. The Nore-Dame Hosptial, the University of Montreal, Quebec, Canada
2. The city of Saint-Jean-sur-Richelieu, Quebec, Canada
In order t
CBT and placebo or CBT and quetiapine. CBT will be administered in 12 weekly two hour CBT sessions given in an individual setting. Individual, rather than group CBT treatment is chosen as there is evi
Sponsors
Astra Zeneca Canada Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between the ages of 18 and 70. 2. Signed an informed consent form and have the capacity to follow the course of the study. 3. Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for depression (unipolar) as well as a Hamilton depression rating scale (HAMD, 21 items) score of 20 or greater at screen (day 0) and 18 or over at randomization (day 28). 4. A Clinical Global Impression (severity scale) score of 4 or greater. 5. Patients will be required to have a diagnosis of refractory major depression as determined by having had; 5.1. At least two sequential 8 week treatments with two different classes of antidepressants. For instance, an 8 week treatment with a Selective Serotonin Reuptake Inhibitor (SSRI) + an atypical antidepressant or alternatively, a SSRI + a TriCyclic Antidepressant (TCA) (this latter class would include venlafaxine) or alternatively, a SSRI + a monoamine oxidase inhibitor. All antidepressants would have had to be administered at the following doses: a. Venlafaxine (regular venlafaxine 300 mg/day; venlafaxine 'Extended Release' (venlafaxine XR) 225 mg/day, for at least 3 of the 8 weeks) b. A tricyclic antidepressant (minimum dose of 150 mg/day equivalent of imipramine for 3 of the 8 weeks) c. A SSRI (at a minimum 40 mg/day for fluoxetine, 30 mg/day for paroxetine and citalopram, 150 mg/day of sertraline and 250 mg/day for fluvoxamine for 3 of the 8 weeks) d. Moclobemide (600 mg/day for 3 of the 8 weeks) e. Nefazodone (500 mg/day for 3 of the 8 weeks) f. Bupropion (250 mg/day for 3 of the 8 weeks) g. An irreversible monoamnie oxidase inhibitor (at maximum posology for 3 of the 8 weeks)
Exclusion criteria
Exclusion criteria: 1. Patients who in the investigator's opinion pose a current risk of suicide. 2. Women of childbearing potential who are pregnant, planning pregnancy in the next 6 months, breast-feeding, or not using medically adequate means of birth control (abstinence, hormonal treatment, Intrauterine Device [IUD]). 3. Any of the following DSM-IV diagnoses: schizophrenia or any other chronic psychotic disorder, personality disorder, panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, somatoform disorder, anorexia nervosa, bulimia, organic mental disorder. 4. Definite or suspected substance abuse in the past 12 months. 5. Serious or unstable medical illness or any co-existing disease or treatment that in the opinion of the investigator contraindicates the use of study drug. 6. Treatment with other psychotropic drugs (prescription or not) other than zopiclone 7.5 mg or temazepam, 15 to 30 mg on a prn ("when necessary") basis for insomnia. 7. Clinically significant laboratory abnormalities at screen. 8. Positive urine screen for drugs of abuse. 9. Known or suspected allergies to psychotropic drugs. 10. Use of any of the following potent cytochrome P450 inhibitors in the 14 days preceding randomization (Day 1) e.g. ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, tironavir, and saquinavir. 11. Use of potent P450 inducers (e.g. phenytoin, carbamazepine, barbiturates, rifampin, glucorticoids) in the 14 days preceding randomization (Day 1). 12. Thyroid-stimulating hormone concentration more than 10% above the upper limit of the normal range, regardless of treatment for hypothyroidism or hyhperthyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variables will be reassessed (HAMD, the Montgomery-Asberg Depression Rating Scale [MADRS] and CGI-S/CGI-I) on day 21 and 28 as well as every two weeks thereafter by raters blind to the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the secondary variables (Extrapyramidal Symptom Rating Scale [ESRS], the Barnes' Akathisia Rating scale and the Heinrich Quality of Life Scale [HQL]) will be performed again at day 112. | — |
Countries
Canada
Outcome results
None listed