Status:
WITHDRAWN
Determinants in Antidepressant Outcomes
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to understand if a biological measurement, of how platelets respond to serotonin (a chemical in the blood sometimes referred to as SERT), can provide information that will deter...
Detailed Description
OBJECTIVE: The objective of this dose-ranging three-arm study of fluoxetine is to study the kinetics of the serotonin transporter in platelets and relate this to antidepressant response by comparing t...
Eligibility Criteria
Inclusion
- A current episode satisfying DSM-IV criteria for Major Depressive Disorder (except controls).
- No psychotropic medication during the previous 2 weeks before baseline (no SSRIs or SNRIs for previous 3 months).
- A current depression score of 20 or greater on the 24-item Hamilton Depression Scale (patients).
- Willingness and ability to give informed consent.
- Age 18 and up.
Exclusion
- Cardiovascular disease; subjects w/ myocardial infarcts within the past 3 months, heart failure, or other evidence of compromised cardiac function
- Uncontrolled hypertension: systolic blood pressure \> 160, or diastolic \> 95
- Previously noted thyroid disease, unless clinically euthyroid for 2 or more months.
- Endocrine disease or exogenous hormones except HRT for postmenopausal women.
- Women not using an effective method of birth control (barrier method, oral contraceptives and/or IUD), pregnant or lactating women.
- Women with menometrorrhagia, premenstrual dysphoric disorder (PMDD), or premenopausal hysterectomized women with intact ovaries, or without HRT.
- Subjects who require concomitant psychotropic medications. Psychotropic medication during the previous 2 weeks before baseline, 3 months for SSRIs or SNRIs, or 4 months for depot neuroleptics.
- Evidence of clinically significant gastrointestinal, hepatic, renal, endocrine, ophthalmologic, neurologic, cardiovascular or hematological disease including anemia, hemophilia, or significant liver disease.
- History of intolerable side effects to the proposed treatment.
- Patients who have ever met DSM-IV criteria for any psychosis, schizophrenia, bipolar disorder, organic brain syndrome or any other primary Axis I major psychiatric disorder other than major depression. Controls must be without past history of depression.
- Patients who meet DSM-IV criteria for any substance abuse during the past 2 months or dependence during the last 6 months, including positive urine drug screens.
- History of priapism
- Subjects who are starting a new psychotherapy program during the 16 weeks of study.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00108316
Start Date
January 1 2004
End Date
September 1 2005
Last Update
September 27 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904