Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00316160
Eligibility Criteria:
Inclusion criteria:
* Primary diagnosis of Major Depressive Disorder (MDD)
* must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
* HAM-D17 total score of \>17 at screening and baseline.
* Severity of illness score of \>4 at screening and baseline.
* Willing to discuss sexual functioning with investigator or designee.
* Sexual activity that leads to orgasm at least every 2 weeks.
Exclusion Criteria:
* Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
* Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
* Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
* Myocardial infarction with 1 year of screening.
* Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
* Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
* Psychotherapy within 3 months.
* Pregnant.
* Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
* ECG or clinical evidence of atrial or ventricular hypertrophy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00316160
Study Brief:
Protocol Section:
NCT00316160