Sertraline vs. Venlafaxine XR

Vanderbilt University

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: sertraline

Drug: venlafaxine XR

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00179283

Sert-Ven

Details and patient eligibility

About

This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline vs. venlafaxine Extended Release in the acute treatment of Major Depression in male and female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated randomized list.

Full description

This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline vs. venlafaxine XR in the acute treatment of Major Depression in male and female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated randomized list.

The primary objectives of the study are: to assess the comparative safety and tolerability of sertraline and venlafaxine XR and to assess number and severity of discontinuation symptoms and time to termination of taper at the end of acute treatment with sertraline vs. venlafaxine XR.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Single or Recurrent Episode of MDD without psychotic features
Additional diagnoses will be permitted only if they are identified as secondary diagnoses
18 or above on 17-item Ham-D with item 1 (depressed mood) score of 2 or above

Exclusion criteria

Current or past diagnosis of Bipolar Disorder
Any history or current psychotic disorder
Current psychotic symptoms, including current delusional depression
Current diagnosis of delirium or dementia
Alcohol or drug abuse or dependence in last 6 months or currently
Schizoid, Schizotypal, or Borderline Personality Disorder
Non-response to sertraline at least 150mg for 4 weeks or more, venlafaxine XR at least 225mg for 4 weeks or more, or non-response to 2 antidepressants in the current episode
Use of any antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
Use of herbal and/or homeopathic remedies concomitantly or within 2 weeks of baseline excluding vitamins and mineral supplements
Use within 1 week of baseline or concomitant use of any psychotropics with the exception zolpidem or zopiclone PRN for sleep
Use within 4 weeks of baseline of benzodiazepines taken on a regular, daily basis (PRN use is acceptable as long as none in week leading up to randomization)
Score of 3 or 4 on the suicide item, item 3 of the Ham-D scale at screen or baseline visit
Participation in any other studies concomitantly or within 90 days prior to entry into this study
Treatment with monoamine oxidase inhibitors within 14 days of baseline
Treatment of electroconvulsive therapy within 30 days of baseline
Previous history or intolerance or hypersensitivity and/or venlafaxine XR
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
Presence of serious and/or unstable medical condition
Abnormal laboratory results
Positive pregnancy test and/or nursing women or fertile women not practicing an effective method of birth control
History seizure disorder-excluding febrile seizures of childhood
Any other condition which in the investigator's judgement might increase the risk to the subject or decrease the chance of obtaining satisfactory data
Mental condition rendering the subject unable to understand the procedures
Unable and/or unlikely to comprehend and/or follow the protocol