This trial is active, not recruiting.

Conditions depression, continuous antidepressant abuse, adverse reaction to drug
Treatment ssri treated group
Sponsor Samsung Medical Center
Start date October 1999
End date December 2003
Trial size 300 participants
Trial identifier NCT01237275, 1999-10-14


First, the investigators examined the functional relevance of serotonin transporter polymorphisms by quantifying the activity of serotonin transporter in blood platelets of genotyped healthy volunteers and patients with major depression.

Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also to the functional expression of 5-HTT in platelets.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
SSRI treated group are depressive patients treated with fluoxetine, paroxetine or sertraline
ssri treated group fluoxetine_Prozac
characterize in arm of a study (SSRI treated group)

Primary Outcomes

Antidepressant Response at 2,4,6 weeks
time frame: 6 weeks

Secondary Outcomes

Biological value at 0 and 6 weeks
time frame: 6weeks

Eligibility Criteria

Male or female participants from 19 years up to 89 years old.

Inclusion Criteria: - Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition. - interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians Exclusion Criteria: - received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks - potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Additional Information

Official title Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients
Principal investigator Doh Kwan Kim, M.D., Ph.D.
Description The purpose of this study is 1. to determine whether serotonin transporter genotypic or functional differences between depressive patients and normal controls were existed. 2. to determine the relationship between serotonin transporter polymorphisms and serotonin transporter functional expression. 3. to determine whether genomic or functional differences between drug responders and nonresponders predict the response of antidepressant
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Samsung Medical Center.