Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000017269
• Date of registration: 24/04/2015
• Prospective Registration: No
• Primary sponsor: Keio University School of Medicine
• Public title: Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study
• Scientific title: 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.
• Date of first enrolment: 2012/03/01
• Target sample size: 75
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020040
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Yukiko MIYASAKA
• Affiliation: Keio University School of Medicine Department of Neuropsychiatry

• Name: Masaru Mimura
• Affiliation: Keio University School of Medicine Department of Neuropsychiatry

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 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.

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

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).

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Pfizer

Ethics review

Status: YES
Approval date:
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