Determinants in Antidepressant Outcomes

NCT00108316 | Withdrawn

• 1 other identifier: MHBS-003-02S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression

Keywords

Depressive Disorder; DNA; Serotonin

Study Arms (1)

Arm 1

OTHER

Drug: Fluoxetine (Liquid Prozac)

Interventions

Fluoxetine (Liquid Prozac) DRUG

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Augusta

Augusta, Georgia, 30904, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Jeffrey Rausch, MD

  VA Medical Center, Augusta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: January 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

US (1)