Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

NCT01237275 | Unknown DMC

• 1 other identifier: 1999-10-14
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Continuous Antidepressant Abuse; Adverse Reaction to Drug

Keywords

Pharmacogenomics; Prediction of Antidepressant Response; Depressed Patients

Outcome Measures

Primary Outcomes (1)

• Antidepressant Response at 2,4,6 weeks

  6 weeks

Secondary Outcomes (1)

• Biological value at 0 and 6 weeks

  6weeks

Study Arms (1)

SSRI treated group

EXPERIMENTAL

SSRI treated group are depressive patients treated with fluoxetine, paroxetine or sertraline

Drug: SSRI treated group

Interventions

SSRI treated group DRUG

characterize in arm of a study (SSRI treated group)

Also known as: fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft

SSRI treated group

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Kangnam, Seoul, South Korea

Location

MeSH Terms

Conditions

Depression; Drug-Related Side Effects and Adverse Reactions

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Doh Kwan Kim, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Ph.D.

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 1999
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2016
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

KR (1)