Patterns of treatment resistance and switching strategies in unipolar affective disorder
- Conditions
- Treatment Resistant DepressionMental Health - Depression
- Registration Number
- ACTRN12610000564055
- Lead Sponsor
- Group for the Study of Resistant Depression
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 320
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method