The Effect of Quetiapine XR in Depressive Patients Showing Aberrant N100 Amplitude Slope
|ClinicalTrials.gov Identifier: NCT01357967|
Recruitment Status : Unknown
Verified October 2012 by Seung-Hwan Lee, Inje University.
Recruitment status was: Recruiting
First Posted : May 23, 2011
Last Update Posted : November 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: SSRI monotherapy Drug: Seroquel XR adjunctive||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Quetiapine XR in Depressive Patients Showing Aberrant N100 Amplitude Slope|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||April 2013|
Experimental: Seroquel XR adjunctive
The quetiapine XR adjunct group will be titrated up to 300mg. Initial dosing will begin at 50mg on Day 1 and 2, increased to 150mg on Day 3 and 4. Further adjustments will be able to be made upwards or downwards within the recommended dose range of 50mg to 300mg depending upon the clinical response and tolerance of the patient. Seroquel XR will be administered daily in the evening.
The dosage of SSRIs will be maintained as low (es-citalopram 5mg, paxil CR 6.25mg, fluoxetine 10mg, and sertraline 25mg).
Drug: Seroquel XR adjunctive
seroquel XR 50mg Day 1 --> 50mg Day 2 --> 150mg Day 3 --> 150mg Day 4 --> adjustment usually at hs but can be daytime
Active Comparator: SSRI monotherapy
Drug: SSRI monotherapy
SSRI (paxil CR, es-citalopram, fluoxetine, sertraline) start with (paxil CR 12.5mg, es-citalopram 10mg, fluoxetine 20mg, sertraline 50mg) for 1 week up to maximal dosage, flexible dosage, usually in the morning
Other Name: SSRI
- 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
- Change from baseline in CGI, BDI, and YMRS scales [ Time Frame: 0,1,2,4,6 weeks ]
- Clincal Global Impression (CGI) : Baseline, 1, 2, 4, 6 week
- Beck Depression Inventory (BDI) : Baseline, 1, 2, 4, 6 week
- Young Mania rating Scale (YMRS) : Baseline, 1, 2, 4, 6 week
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357967
|Contact: Jung In Kim, Mremail@example.com|
|Korea, Republic of|
|Psychiatry Department, Inje University Ilsan Paik Hospital||Recruiting|
|Goyang, Geyonggi, Korea, Republic of|
|Principal Investigator: Seung-Hwan Lee, MD, PhD|
|Inje University Ilsanpaik Hospital||Active, not recruiting|
|Goyang, Gyeonggi, Korea, Republic of, 411-706|
|Principal Investigator:||Seung-Hwan Lee, MD, PhD||Psychiatry Department Inje University Ilsan Paik Hospital|