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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Seung-Hwan Lee, Inje University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Seung-Hwan Lee, Inje University Identifier:
First received: May 19, 2011
Last updated: October 31, 2012
Last verified: October 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 Intervention Phase
Major Depressive Disorder Drug: SSRI monotherapy Drug: Seroquel XR adjunctive Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Quetiapine XR in Depressive Patients Showing Aberrant N100 Amplitude Slope

Resource links provided by NLM:

Further study details as provided by Seung-Hwan Lee, Inje University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Quetiapine group:

seroquel XR 50mg Day 1 --> 50mg Day 2 --> 150mg Day 3 --> 150mg Day 4 --> adjustment usually at hs but can be daytime

Other Names:
  • Seroquel XR
  • quetiapine XR
  • quetiapine
Active Comparator: SSRI monotherapy
active comparator
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

For inclusion in the study patients must fulfill all of the following criteria:

  1. Major depressive disorder (HRDS > 18)
  2. N100 amplitude slope outlier (< 0.21 or > 1.59)
  3. Aged 18 to 55 years
  4. Provision of written informed consent prior to any study specific procedures

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

  1. Pregnancy or lactation: : urine HCG (-)
  2. Any DSM-IV Axis I disorder not defined in the inclusion criteria
  3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  4. Known intolerance or lack of response to quetiapine fumarate and SSRI antidepressant, as judged by the investigator
  5. Hearing impairment
  6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
  7. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
  8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation/baseline
  9. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
  11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  12. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension or clinically relevant abnormal laboratory values) as judged by the investigator
  13. Involvement in the planning and conduct of the study
  14. Previous enrollment or randomisation of treatment in the present study.
  15. Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
  16. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria

    • Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) > 8.5%
    • Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
    • Physician responsible for patient's DM care has not approved patient's participation in the study
    • Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
  17. An absolute neutrophil count (ANC) of <= 1.5 x 1,000,000,000 per liter
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01357967

Contact: Jung In Kim, Mr 82-31-910-7776

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
Sponsors and Collaborators
Inje University
Principal Investigator: Seung-Hwan Lee, MD, PhD Psychiatry Department Inje University Ilsan Paik Hospital
  More Information

Additional Information:
Responsible Party: Seung-Hwan Lee, Professor, Inje University Identifier: NCT01357967     History of Changes
Other Study ID Numbers: Seroquel ISS D1443C00053
Study First Received: May 19, 2011
Last Updated: October 31, 2012

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 21, 2017