Track topics on Twitter Track topics that are important to you
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS).
Subjects will be patients who are referred to the outpatient or inpatient clinic of gastroenterology departments of province level general hospitals in China. All subjects present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written informed consent prior to participating in the study. Subjects will be assessed for eligibility at a screening visit, with eligible patients returning for a assessment within 1 week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose: 12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study treatment visits.
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine CR in patients with MDD comorbid IBS.
This study is designed with a 1-week screening period, followed by 8 weeks of treatment and 1 week follow up period, 7 visits totally; the calculation of visit date is base on the real date of random date.
Visit 1: a screening period for within 7 days to determine eligibility for the study, subjects aged ≥ 18 and ≤ 65 years at the time of screening, must have a diagnosis of IBS and MDD. After giving their informed consent to participate in the study, patients will undergo screening assessments, including demographic data (birth, race, gender, height, weight), medical history, disease history, therapy history, concomitant medication, physical examination, vital signs, 12-lead ECG and laboratory assessments.
The treatment phase will last for 8 weeks. The visit (except baseline) will have ±3 days.
Visit 2 (Day 0, baseline visit): Patients who fulfil all the study inclusion and exclusion criteria will accept baseline assessment (including concomitant medication, vital signs and scale assessment) and be randomised into paroxetine CR plus IBS regular treatment group or IBS regular treatment only group at baseline visit. The day after randomizing (Day 1), patients will receive paroxetine CR 12.5mg/d plus IBS regular treatment or IBS regular treatment only (patients who have received IBS regular treatment before can continue their treatment). On Day 8, following 1 weeks of treatment, paroxetine CR should be titrated to 25mg/d.
Visit 3-5 (Day 14, Day 28, Day 42): Efficacy and safety assessments will be performed at these visits, including vital signs and HDRS-17 (Hamilton Depression Rating Scale 17 items), CGI-S (Clinical Global Impression- Severity), CGI-I (Clinical Global Impression- Improvement), WHOQOL (World Health Organization Quality of Life Assessment), IBSSS (The Irritable Bowel Severity Scoring System). From Week 3 to 6, the investigator can titrate the subject's dose upwards according to clinical response and tolerability, at a maximum rate of paroxetine CR 12.5mg every 14 days. For example, if CGI-I is ≥3 based on the assessment at scheduled clinic visit, and the patient is able to tolerate an increased dose, the dose increment to the next dose level shall be considered. The highest dose that may be administered is paroxetine CR 50 mg and dose titration may only occur at scheduled visits.
Visit 6 (Day 56): Efficacy and safety assessments will be performed at these visits, including vital signs, physical examination, laboratory assessments and HDRS-17, CGI-S, CGI-I, WHOQOL, IBSSS.
If the patient experiences an adverse event (AE) and the investigator deems that a reduction in dose is required then the patient may be administered a dose one level (paroxetine CR 12.5 mg) lower than they were taking previously. Upon resolution of the AE, the investigator may return to patient's pre-AE dose level.
After treatment phase, the investigator should communicate with all the subjects about the follow-up choice: reduce or continuing paroxetine CR treatment/ other antidepressants treatment/ transferring to psychiatric clinics. It is not recommend to reduce drug dosage during the treatment period of MDD.
For those subjects who decide to discontinue paroxetine CR treatment: a gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. The dosage should be reduced weekly, the daily dose reduction is 12.5mg per week, and once a week. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Visit 7 (Day 63): the investigator should conduct safety follow up by phone call to all participants to investigate the medication situation and safety related information.
Patients withdrawn from the study prior to Visit 6 (Week 8) will have all end-of-study procedures performed. Patients withdrawn from the study for any reason are to attend an early withdrawal visit on withdrawal from the study. In addition, patients have to taper the study drug if they end the study on a dose level higher than dose level 1 (paroxetine CR 12.5 mg). The dosage should be reduced weekly, the daily dose reduction is 12.5mg per week, and once a week.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Published on BioPortfolio: 2014-08-27T04:00:43-0400
The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combinati...
This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in childr...
The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to Paroxetine Immediate Release, as well as the drug tolerability profile when treated on patients wi...
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receiv...
This study compares the efficacy of risperidone to that of paroxetine in the treatment of panic attacks in patients with Panic Disorder and with Major Depressive Disorder with Panic attack...
The study aimed to investigate the impacts of persistent depressive disorder (PDD) and pharmacotherapy on depression, anxiety, and somatic symptoms among patients with major depressive disorder (MDD) ...
This randomized, placebo-controlled, crossover trial examined the antidepressant efficacy of the muscarinic antagonist scopolamine in major depressive disorder subjects with more severe and refractory...
We explored the predictors of co-occurring depressive disorder (DD) in individuals with posttraumatic stress disorder (PTSD) in an outpatient psychiatric setting.
The severity of depressive symptoms across two discrete mental disorders should be evaluated with the same psychometrically validated tools. In patients with schizophrenia the Calgary Depression Ratin...
Structural changes of brain areas have been reported in depressive disorder and suicidal behavior (SB), in which TPH1 also has been known as a promising candidate gene. We investigated gray matter vol...
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
Irritable Bowel Syndrome IBS
Irritable bowel syndrome (IBS) is a common but poorly understood chronic (long-term) condition where the normal functions of the bowel are disrupted. Symptoms of IBS include abdominal pain or discomfort, changes in bowel habits and bloated feelings. ...
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...