A comparative study of the efficacy and safety of Agomelatine 25 mg (or 50 mg) and Paroxetine 20mg (or 30 mg) in patients with major depressive disorder (MDD)
- Conditions
- Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features
- Registration Number
- CTRI/2012/03/002480
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Human male and/ or female Patients within 18 to 65 years of age (inclusive) leaving in India.
2.Adult patients of Major Depressive Disorder (MDD). [Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria, HAM-D total score should be more than or equal to 20]
3.CGI-S greater than or equal to 4
4.Hospital Anxiety Depression Scale HAD depression sub-score greater than or equal to 11
5.Sheehan disability scale: SDS auto-completed
6.Not having any significant diseases or clinically significant abnormal findings except Major Depressive Disorder (MDD) during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
7.The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study. If the respective lab values are outside the reference range, the investigator must document in the patientâ??s file and CRF that he/she foresees no related risk if the patient will be treated within the trial.
8.Able to comply with study procedures in the opinion of the investigator.
9.Patients must demonstrate adequate decisional capacity to make a choice about participating in this research study and must provide informed consent to participate.
10.In case of female patients:
They must have been surgically sterile at least for 6 months prior to participation in trial (documentation of sterilization must be provided);
OR
Those who are of child bearing potential must be using a suitable and effective double contraceptive method during the study. Results of the pregnancy test done at screening must be negative and available prior to dosing.
Women of childbearing potential (WOCP) must have a negative ï?¢ Hcg test at screening. WOCP must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives throughout the period of study drug exposure and for 30 days after the last dose of study drug. Acceptable contraceptives include IUDs and double barrier methods (such as condom or diaphragm with spermicidal gel).
WOCP should not participate in artificial insemination procedures and must agree not to become pregnant during the period of study drug exposure, and for 30 days after the last dose of study drug. WOCP who are not currently sexually active, must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of study drug exposure and must agree not to become pregnant for 30 days after the last dose of study drug. Women not of childbearing potential are defined as those who have been surgically sterilized (at least 6 months prior to screening) or who have been postmenopausal for at least 12 consecutive months. (Investigator will be responsible for determining whether the patient is using appropriate birth control measures for study participation)
1.History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder.
2.Any current Axis I disorder other than major depressive disorder which is the focus of treatment.
3.Current violent behaviour.
4.History of syncope, or orthostatic hypotension
5.Positive testing for the drugs of abuse (amphetamines, opioids, cocaine, methadone, marijuana or any cannabinoids, barbiturates, phencyclidine) done by urine scan at Screening.
6.Substance or alcohol dependence within 3 months before randomization.
7.The presence of clinically significant abnormal laboratory values during screening.
8.A positive hepatitis screen including hepatitis B surface antigen, HCV antibodies.
9.A positive test result for HIV antibody.
10.Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.
11.Any condition/ Abnormal baseline findings that in the investigatorâ??s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
12.Psychosis judged to be the direct physiological effect of an abused medication or substance.
13.Patients with a known intolerance or lack of response to previous treatment with the molecule closely related Agomelatine. (e.g. fluoxetine)
14.Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission.
15.History or known case of Organic Brain Disease.
16.Patients with the abnormal cardiac conditions
17.History of seizure disorder (except febrile convulsions)
18.Patients having Hypertension or on anti hypertensive medications
19.Patients with Diabetes mellitus
20.Dementia related psychosis
21.Pregnant (refer inclusion criteria no 10) or lactating females
22.Electroconvulsive therapy (ECT) within 30 days prior to randomization
23.Patients known to be non-responders to Paroxetine or Agomelatine treatment or resistant to Paroxetine or Agomelatine for the current episode.
24.Patient under behavioral or Pharmacological treatment of depression or stabilized by an antidepressant for the current episode.
25.Patient treated with Transcranial Magnetic Stimulation (TMS) within the last three months before selection.
26.Hypo or hyprethyroidism except if the treatment has been stabilized for at least 3 months.
27.Known hypersensitivity to Agomelatine or Paroxetine or any of the excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in HAMD scores from baseline to end of 6 weeks therapyTimepoint: Improvement in HAMD scores from baseline to end of 6 weeks therapy
- Secondary Outcome Measures
Name Time Method â?¢Clinical Global Impression- Severity (CGIS): Screening <br/ ><br>â?¢Clinical Global Impression- Change (CGIC) : End of Study <br/ ><br>â?¢Hamilton Anxiety Rating Scale <br/ ><br>â?¢Hospital Anxiety and Depression Scale <br/ ><br>â?¢Sheehan Disability Scale <br/ ><br>â?¢Leeds Sleep Evaluation Questionnaire â?¢Any deviation from the routine health status (clinical or laboratory)Timepoint: screening, end of study
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.