Clinical trial NCT04093960: Escitalopram Plus PS128 vs. Escitalopram
Official title: A Randomized, Double-blind, Comparison of the Efficacy and Safety of Escitalopram Plus PS128 to Escitalopram in the Acute Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Major Depression
Keywords: psychobiotics
major depressive disorder
escitalopram
Lead sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-18
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Major depressive disorder
* CGI \>=4
* the score of the 17-item Hamilton Rating Scale for Depression (HAMD-17) was 18 or higher.
* washout of antipsychotics at least 3 days
* written informed consents
* Not taking fluoxetine at least one month before admission.

Exclusion Criteria:

* History of schizophrenia, schizoaffective disorder or organic mental disorders.
* comorbid with substance abuse/dependence in the past 6 months.
* with psychotic features
* treatment-resistant depression or receiving electroconvulsive therapy.
* History of serious adverse events to escitalopram
* female subjects with pregnancy or lactation.
* severe physical illness
* receiving antibiotics treatment in the past two weeks.
* taking products with probiotics.

Primary outcomes:
measure: Depression severity by the change of 17-item Hamilton Rating Scale for Depression (HAMD-17) total scores
timeFrame: Time Frame: The HAMD-17 was rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Secondary outcomes:
measure: Clinical severity by Clinical Global Impression-Severity (CGI-S)
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
measure: Assessments of safety for general adverse events
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
measure: Change of body weights
timeFrame: Time Frame: Body weights were assessed at baseline and week 6(or on early termination).
measure: Change of body mass index (BMI)
timeFrame: Time Frame: BMI was assessed at baseline and week 6(or on early termination).
measure: Change of pulse rate
timeFrame: Time Frame: Pulse rates were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).
measure: Change of blood pressure
timeFrame: Time Frame: Blood pressure were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).
measure: Change of ECG QT Interval
timeFrame: Time Frame: ECG were assessed at baseline and week 6 (or on early termination).
measure: change of fasting glucose.
timeFrame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6(or on early termination.
measure: change of liver function
timeFrame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6 (or on early termination).
measure: change of renal function
timeFrame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6 (or on early termination).
measure: change of lipid profiles.
timeFrame: Time Frame: laboratory test mentioned above were assessed at baseline and week 6(or on early termination).
measure: Assessments of quality of life
timeFrame: Time Frame: Medical Outcomes Study Short-Form 36 was assessed at baseline and week 6
measure: Assessments of heart rate variability
timeFrame: Time Frame: Heart rate variability was assessed at baseline and week 6
measure: depression and somatic symptoms evaluation
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
measure: Gastrointestinal Symptoms evaluation
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
measure: Sleep Quality evaluation: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
measure: Function evaluation
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
measure: change of work and social adjustment
timeFrame: The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
Study officials:
References: