Unique ID issued by UMIN | UMIN000017269 |
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Receipt number | R000020040 |
Scientific Title | Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study |
Date of disclosure of the study information | 2015/04/24 |
Last modified on | 2015/04/24 18:40:54 |
Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study
Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression.
Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study
Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression.
Japan |
Depression
Psychiatry |
Others
NO
1)The primary objective of this study is to investigate specific pre-treatment hemodynamic pattern which may predict response to the 12-week sertraline treatment in patients with acute non-psychotic major depressive disorder. Other demographic and clinical factors will also be compared between treatment responders and non-responders.
2)We will also compare prefrontal activation during executive-control task and emotional judgment task between responders and non-responders after a 12-week sertraline treatment.
3)Finally, the changes in hypofrontality measured by NIRS during executive-control task and emotional judgment task and depression severity during the sertraline treatment period will be investigated as well.
Safety,Efficacy
Baseline concentrations of oxygenated hemogloblin [oxy-Hb] during VFT (letter-based word retrieval) and EJT measured by NIRS will be compared between treatment responders and non-responders. Responders will be defined as those who score 50% or greater reduction on baseline GRID-HAMD17 score at the week 12.
1.Changes between baseline and the 12 week concentrations of oxy-Hb during VFT and EJT measured by NIRS will be compared between treatment responders and non-responders.
2.Severity of objective depression as measured by GRID HAMD17 and severity of subjective depression as measured by BDI-2.
3.Remission rate at week 12 (Remission will be defined as 7 or less on GRID-HAMD17)
4.Level of quality of life as measured by the European Quality of Life Questionnaire Dimensions (EQ-5D).
5.Level of global burden of side-effect as measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) Scale.
6.Safety and tolerability will be measured by serious adverse event reports (SAEs) and premature discontinuation rate at week 12.
7.The 16-item Quick Inventory of Depressive Symptomatology Self-Reported (QIDS-SR16) will be measured during the protocol treatment for monitoring safety and the acquisition of treatment.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
The protocol strongly encourages all patients to receive sertraline 100 mg/d for 12 weeks using a flexible dose schedule to maximize the chances of obtaining a remission, except for those with clear intolerance. Initial strategy will be to titrate sertraline up to the minimum dose of the effective range (50 mg/d). If <20% reduction in baseline symptom severity as measured by the QIDS-SR16 is found at week 4, the minimum of the effective range (50mg/d) will be titrated (assuming tolerable side effects) to the maximum dose of the effective range (100 mg/d). However, appropriate flexibility will be allowed in dose escalation schedule (i.e. a slower or faster escalation schedule), so that patients with concomitant general medical disorders, with other psychiatric disorders or those who are sensitive to side effects can be managed well and included safely in the sample, in order to optimize the chances of therapeutic benefit for each patient.
The recommended treatment visits will be at 0, 2, 4, 6, 8, 10 and 12 weeks. Exit from study, according to the protocol is week 12 (time-point (t3)). Optional visits are allowed between bi-weekly visits if needed. Sessions will typically last about 15 to 30 minutes, and focus on burden of symptoms and side effects in supportive manner. Non-specific psychotherapies, exercise, psychoeducation and brief problem-solving are allowed. Intolerance is declared if a participant discontinues sertraline during the initial 4 weeks for any reason or intolerable side effects that require the medication to stop sertraline at a point subsequent to the 4th week of treatment (independent of the symptomatic status).
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1.Fulfill criteria for major depressive disorder, as defined by DSM-IV criteria without psychotic features, as determined by clinical assessment and confirmed by the SCID at screening (t1).
2.Aged 20-65 years at t1.
3.Have a GRID-HAMD17 total score 16 at t1 and baseline (t2).
4.The major depressive disorder is the primary diagnosis for the treatment and treating physician has judged sertraline to be appropriate for prescribing.
5.Have an education level and a degree of understanding such that the patient can communicate with the study personnel.
6.Patients must be competent and able to give their own informed consent.
1.Have had any additional ongoing DSM-IV Axis I condition other than major depressive disorder that is considered as the primary diagnosis within 1 year of t1.
2.Have a current or lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder at t1.
3.Have a history of substance abuse/dependence within 1 year of t1, not including caffeine and nicotine.
4.Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
5.Have an evidence of being resistant to sertraline 100 mg/d (maximum dose of the effective range) for at least 6 weeks during this current depressive episode.
6.Women who are currently pregnant or breastfeeding.
7.Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others.
8.Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, renal disease, or clinically significant laboratory or ECG abnormality.
9.Have a history of traumatic head injury or organic brain syndrome such as stroke.
75
1st name | |
Middle name | |
Last name | Masaru Mimura |
Keio University School of Medicine
Department of Neuropsychiatry
35 Shinanomachi,Shinjuku-ku,Tokyo JAPAN
03-5363-3829
mimura@a7.keio.jp
1st name | |
Middle name | |
Last name | Yukiko MIYASAKA |
Keio University School of Medicine
Department of Neuropsychiatry
35 Shinanomachi,Shinjuku-ku,Tokyo JAPAN
03-5363-3829
miyasaka@a5.keio.jp
Keio University School of Medicine
Pfizer
Profit organization
NO
2015 | Year | 04 | Month | 24 | Day |
Unpublished
Open public recruiting
2012 | Year | 02 | Month | 27 | Day |
2012 | Year | 03 | Month | 01 | Day |
2015 | Year | 04 | Month | 24 | Day |
2015 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020040
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