Depression
Conditions
Brief summary
This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.
Interventions
DRUGEffexor® (Venlafaxine)
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1). * A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2). * Patients above 18 years of age who meet the eligibility requirements.
Exclusion criteria
* Patients taking MAOI's within 2 weeks prior to the survey. * Patients known to be suffering from bipolar disorder or schizophrenia. * Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy. * Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®. | — |
Outcome results
None listed