Determinants in Antidepressant Outcomes

• Status: Withdrawn
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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 determine an "ideal dose," one specifically tailored for each individual's chemistry. The biological measurement will be obtained by testing a blood sample. There will be approximately 120 control subjects expected for enrollment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Antidepressive Agents; Fluoxetine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.