Escitalopram Plus PS128 vs. Escitalopram

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.

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".

Body weights

body mass index (BMI)

pulse rate

blood pressure (both systolic and diastolic)

12-lead electrocardiogram (ECG) ECG QT Interval.

Laboratory tests including fasting glucose.

Laboratory tests including alanine aminotransferase [ALT] and aspartate aminotransferase [AST].

Laboratory tests including blood urea nitrogen [BUN], creatinine.

Laboratory tests including triglycerides, cholesterol, high density lipoprotein [HDL], and low density lipoprotein [LDL].

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.

Heart rate variability

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.

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).

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%.

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.

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)