NCT01357967 is a Phase 4 clinical trial of SSRI monotherapy in Major Depressive Disorder, sponsored by Inje University.

Who is sponsoring NCT01357967?

NCT01357967 is sponsored by Inje University.

What drugs are being tested in NCT01357967?

Interventions in NCT01357967: SSRI monotherapy, Seroquel XR adjunctive.

What condition does NCT01357967 study?

NCT01357967 studies Major Depressive Disorder.

Is NCT01357967 still recruiting?

NCT01357967 is currently status unknown. Last updated 31 October 2012.

Last reviewed 2012-10-31 · How we verify

NCT01357967

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of Quetiapine XR in Depressive Patients Showing Aberrant N100 Amplitude Slope

Status unknown Phase 4 Last updated 31 October 2012

What this trial tests

Phase 4 trial testing SSRI monotherapy in Major Depressive Disorder in 60 participants. Status unknown.

Timeline

1 May 2011

Primary endpoint
1 December 2012

1 April 2013

Quick facts

Lead sponsor	Inje University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 May 2011
Primary completion	1 December 2012
Estimated completion	1 April 2013
Sites	2 locations across South Korea

Drugs / interventions tested

SSRI monotherapy — full drug profile →
Seroquel XR adjunctive — full drug profile →

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Inje University

Who can join

Adults 18 to 55, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in HDRS scale
Time frame: 0,1,2,4,6 weeks
-Hamilton Depression Rating Scale (HDRS) : Baseline, 1, 2, 4, 6 week

Sponsor's own description

Recently, there are increasing data about intensity dependent amplitude change (IDAP: N100 amplitude slope) of auditory evoked Event Related Potential (ERP) components for its role on surrogate marker of central serotonergic activity. A high N100 amplitude slope reflects low serotonergic neurotransmission and vice versa. There are a couple of studies reporting associations of N1 amplitude slope with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients (2,3). The investigator also published a case series about SSRI super-sensitivity and SSRI induced mania in patients with aberrantly high N100 slope (4). And serotonin transporter gene polymorphism was studied for its role about pathophysiology of bipolar disorder (5, 6, 7). Serotonin promoter gene was known to have significant relationship with N100 amplitude slope (8). Furthermore previous study showed that N100 amplitude slope was well correlated with hypomanic and hyperthymic personality (9). Conclusively from above results, the investigator hypothesized that if depressive patients show aberrant high or low N100 amplitude slope (N100 response outliers), they will not response well to SSRI medication. They will response better to quetiapine XR adjunctive therapy. In this study, the investigator will confirm it by comparing treatment effect between SSRI monotherapy and quetiapine XR adjunctive in aberrant N100 responder. Hypothesis First visit depressive patients might have monopolar or bipolar depression. If depressive patients show aberrantly high or low N100 amplitude slope, they will not response to SSRI medication. Patients who have aberrantly high or low N100 amplitude slope will response better to quetiapine XR adjunctive therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

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NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Inje University trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01357967 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inje University
Last refreshed: 31 October 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01357967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing