None listed
Conditions
Brief summary
Although more and more effective treatment strategies are available to manage depression, 20 to 30 % of depressed patients still remain unhelped (Treatment Resistant Depression - TRD). The importance of this problem must also be considered in regard to numerous documented treatment algorithms and strategies in the literature, including drug combinations and potentiations. This study will address the issue of the antidepressant switching strategies for TRD. Objective: To compare switching strategies of specific Noradrenergic and Serotoninergic treatments for depressed inpatients and outpatients who are not responding to an adequate therapeutic trial of antidepressant.
Interventions
patients not responding to one or more previous antidepressant treatment are randomly allocated to:
CITALOPRAM (CITA) 40-60 mg oral tablet once daily for 4 weeks vs DESIPRAMINE (DESI) 150-200 mg oral tablet twice daily for 4 weeks trials.
The non-responder patients after 4 weeks will be immediately divided in 4 arms with no wash out including
- 2 arms for continuation of the same antidepressant (AD) ('CITA' - 'CITA' and
'DESI' - 'DESI') at the same dose for 4 weeks.
- 2 arms for swiching from
patients not responding to one or more previous antidepressant treatment are randomly allocated to: CITALOPRAM (CITA) 40-60 mg oral tablet once daily for 4 weeks vs DESIPRAMINE (DESI) 150-200 mg oral tablet twice daily for 4 weeks trials. The non-responder patients after 4 weeks will be immediately divided in 4 arms with no wash out including - 2 arms for continuation of the same antidepressant (AD) ('CITA' - 'CITA' and 'DESI' - 'DESI') at the same dose for 4 weeks. - 2 arms for swiching from 'CITA' to 'DESI' and 'DESI' to 'CITA' for 4 weeks. Flexible doses are allowed according to tolerance and efficacy: - DESI: In some cases the maximum tolerated dose can be less than 200 mg, but must be at least 150 mg. - The period to reach 150 mg or 200 mg of DESI can be adapted in function of tolerability. The dose can be reached slowly (but no more than 1 month in total), but it is mandatory to have at least 2 weeks of minimal dose (more than 150 mg). This means that some patients will be treated for 5 or 6 weeks. The same flexibility can be applied to citalopram for which the minimal dose is 40 mg. - For patients > 65 years, the maximum doses are 200 mg/day for DESI and 40 mg/day for CITA. -The highest dose administered will be maintained until the end of the study whenever possible. However, at any time after visit 2, the investigator may reduce a patient's dose to improve tolerance.
Sponsors
Group for the Study of Resistant Depression
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
a. Failure to respond to an adequate trial of antidepressant except CITA and DESI (special cases: Patients who are treated with fluoxetine can be included only after switching to a short term antidepressant for 4 weeks. Similarly, patients treated by Monoamine oxidase inhibitors (MAOI) can be included only after a switch to moclobemide for 4 weeks. b. HDRS more 17 (non remission) at screening c. Provide written informed consent.
Exclusion criteria
a. Major depressive episode with psychotic features b. Major depression of patient with bipolar affective disorder c. Concomitant severe axis II disorders (Borderline, paranoid, histrionic, antisocial, schizoid, schizotypal) d. Drug or alcohol dependence, as defined in Diagnostic and Statistical Manual of Mental Disorder-IV e. Concomitant obsessive compulsive disorder, post traumatic stress disorder, Schizophrenia f. Affective disorder associated to a serious general medical condition not stabilized. g. Seizure disorder other than a single childhood febrile seizure h. Acute suicidal risk requiring alternative treatment(s) i. Myocardial infarction within 6 months prior to screening (visit 1). j. Clinically significant hepatic or renal disease or any other disease that might compromise the study or be detrimental to the patient. k. Uncontrolled hypertension. Patients whose hypertension is controlled with antihypertensive drugs will be allowed into the study
Outcome results
None listed