Major Depressive Disorder
Conditions
Interventions
After 6 weeks of open treatment with a standard dose of paroxetine (20 mg/day) the patients who have not responded (<50% decrease in baseline HDRS-17) will be randomised to receive either a true or a
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Major Depressive Disorder according to DSM-IV (determined by Structured Interview for DSM-IV (SCID-I)); 2. 17-item Hamilton Depression Rating Scale (HDRS-17) >18; 3. Age 18 to 70 years; 4. Maximally 1 previous treatment-trial with an antidepressant (of adequate duration [6 weeks] and dosage [maximum recommended dose]) for the current MDD episode.
Exclusion criteria
Exclusion criteria: 1. Bipolar disorder, psychosis or cognitive impairment (dementia or low IQ); 2. Use of psychoactive medication (except low doses of benzodiazepines); 3. Previous adequate trial with paroxetine with insufficient response for the current episode; 4. Primary alcohol- or drugs abuse; 5. MDD secundary to comorbid anxiety- or somatophorm disorder; 6. Somatic illnesses (e.g. untreated thyroid or other endocrine illnesses, systemic illnesses); 7. Pregnancy or wish to become pregnant; 8. Severe and acute suicidality; 9. Insufficient knowledge of Dutrch to fill in questionnaires.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurence of side-effects (physical and sexual); 2. Subjective well-being and MOS-SF36 quality of life; 3. Direct and indirect costs (TiC-P). | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Response and remission rates (decrease of >= 50% in HDRS-17 and HDRS-17 <= 7 respectively); 2. Total and specific (due to side-effects or inefficacy) drop-out. | — |
Contacts
Public ContactA.H. Schene
Academic Medical Center (AMC), Program for Mood Disorders, Department of Psychiatry, P.O. Box 22660
Outcome results
None listed