The purpose of this study is to compare the efficacy and safety of escitalopram plus PS128 to escitalopram in the acute treatment of patients with major depressive disorder.
In this 6-week, double-blind, fixed-dose study, patients with major depressive disorder are randomly assigned to escitalopram (10 mg daily) plus PS128 (a psychobiotic) (300 mg two times daily, equivalent to 3 ×1010 CFU two times daily) or escitalopram (10 mg daily) groups. The rating scales and instrument, including Clinical Global Impression-Severity, 17-item Hamilton Rating Scale for Depression, Hamilton Anxiety Rating Scale, Global Assessment of Functioning, Heart Rate Variability, Depression and Somatic Symptoms Scale, Work and Social Adjustment Scale, Short form 36 and Pittsburgh Sleep Quality Index, are used to measure treatment outcomes at weeks 0, 1, 2, 3, 4, 5, and 6. UKU Side Effect Rating Scale and Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome are used to measure side effects. Generalized estimating equations model will be used to analyze the differences between two groups with respect to efficacy and safety measures on time after adjusting for baseline severity, sex, age and age at onset of illness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
10 mg qd of escitalopram qd plus 300mg bid of Lactobacillus plantarum PS128 to enhance antidepressive effect
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
Kaohsiung City, Taiwan
Depression severity by the change of 17-item Hamilton Rating Scale for Depression (HAMD-17) total scores
17-item Hamilton Rating Scale for Depression (HAMD-17) is widely used in clinical setting to evaluate depression symptoms in the past week. Higher total HAMD-17 scores (ranging from 0 to 52) indicate more severe depression.
Time frame: Time Frame: The HAMD-17 was rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Clinical severity by Clinical Global Impression-Severity (CGI-S)
The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises one-item measures evaluating the severity of psychopathology from 1 to 7 and higher scores indicate higher severity.
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Assessments of safety for general adverse events
General adverse events were evaluated by a standardized the UKU Side Effect Rating Scale. A score of 1, 2 or 3 on any UKU item that first occurred or worsened during treatment indicated adverse events "cases".
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Change of body weights
Body weights
Time frame: Time Frame: Body weights were assessed at baseline and week 6(or on early termination).
Change of body mass index (BMI)
body mass index (BMI)
Time frame: Time Frame: BMI was assessed at baseline and week 6(or on early termination).
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Change of pulse rate
pulse rate
Time frame: Time Frame: Pulse rates were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).
Change of blood pressure
blood pressure (both systolic and diastolic)
Time frame: Time Frame: Blood pressure were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).
Change of ECG QT Interval
12-lead electrocardiogram (ECG) ECG QT Interval.
Time frame: Time Frame: ECG were assessed at baseline and week 6 (or on early termination).
change of fasting glucose.
Laboratory tests including fasting glucose.
Time frame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6(or on early termination.
change of liver function
Laboratory tests including alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Time frame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6 (or on early termination).
change of renal function
Laboratory tests including blood urea nitrogen \[BUN\], creatinine.
Time frame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6 (or on early termination).
change of lipid profiles.
Laboratory tests including triglycerides, cholesterol, high density lipoprotein \[HDL\], and low density lipoprotein \[LDL\].
Time frame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6(or on early termination).
Assessments of quality of life
The Short-Form-36 (SF-36) is comprised of the physical component summary (PCS) which measures physical health, and the mental component summary (MCS) which measures mental health. PCS includes 4 subscales: 1) physical functioning, 2) role physical limitations, 3) body pain, 4) general health; MCS includes 4 subscales: 1) vitality, 2) social functioning, 3) role emotional limitations, and 4) mental health. SF-36 raw scores were processed according to the user manual to obtain standardized scores for all 8 SF-36 subscales, PCS and MCS. Scores for the SF-36 subscales range from 0 to 100, with a higher score representing better QOL. The PCS and MCS were standardized according to general population means and variances to produce scores with a common mean of 50 and standard deviation of 10 (T-scores). Thus, any score \< 50 represents a reduction from "normal" health.
Time frame: Time Frame: Medical Outcomes Study Short-Form 36 was assessed at baseline and week 6
Assessments of heart rate variability
Heart rate variability
Time frame: Time Frame: Heart rate variability was assessed at baseline and week 6
depression and somatic symptoms evaluation
The Depression and Somatic Symptoms Scale (DSSS) is composed of a 12-item depression subscale (DS) and a ten-item somatic subscale (SS), which includes a five-item pain subscale (PS). Each item is scored from 0 to 3 (absent, mild, moderate, and severe) according to the severity of symptoms, with the total score ranging from 0 to 36 and 0-30 for the DS and the SS, respectively. Higher total score indicates more severe depression and somatic symptoms.
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Gastrointestinal Symptoms evaluation
Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS) includes 15 questions on a scale of 1 to 7, depending on how inconvenient it had been during the previous week. A higher score indicates more inconvenient symptoms. Combination scores among 15 questions can assess the following five domains: reflux syndrome (heartburn and acid regurgitation), abdominal pain (stomach ache, gastric hunger pains and nausea), indigestion syndrome (gastric borborygmus, gastric bloating, eructation and increased flatus), diarrhea syndrome (diarrhea, loose stools and urgent need to defecate) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation).
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Sleep Quality evaluation: The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. In distinguishing good and poor sleepers, a global PSQI score \> 5 yields a sensitivity of 89.6% and a specificity of 86.5%.
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Function evaluation
Global Assessment of Functioning (GAF) is used to rate severity of illness in psychiatry and covers the range from positive mental health to severe psychopathology. It is an overall (global) measure of how patients are doing Internationally, recording GAF is either done with a single value (this is the most severe of the symptom and functioning values) or both symptom (GAF-S) and functioning (GAF-F) values are recorded. The symptom and functioning scales have both 100 scoring possibilities (1-100). The 100-point scales are divided into 10 intervals, or sections, each with 10 scoring possibilities (examples: 31-40 and 51- 60). Verbal instructions (called anchor points) describe symptoms and functioning relevant for scoring in the 10-point intervals.
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
change of work and social adjustment
Work and Social Adjustment Scale(WSAS) is a widely used questionnaire by patients' perspectives concerning impaired functioning. The WSAS comprises 5 items (work, home management, social leisure, private leisure, and relationships; see Appendix A), each rated on a scale of 0 to 8, which can also be pooled (total score 0-40; higher scores denote more disability)
Time frame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).