Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified
Conditions
Interventions
Intervention1: FDC of Dextromethorphan Hydrobromide 45 mg plus Bupropion Hydrochloride 105 mg Extended Release Tablets: Days 1 to 3
Patients will be advised to take study drug orally on an empty stoma
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 65 years (both inclusive). 2. Patients currently meets the DSM-5 criteria for MDD without psychotic features, with a current major depressive episode of at least 4 weeks in duration at visit 1. 3. Patients with MADRS score of = 25 and CGI-S = 4 at screening (visit 1) and baseline (visit 2). 4. Patients with normal physical examination findings and clinical laboratory test results from screening (visit 1) or abnormal results that are judged not clinically significant by the investigator. 5. Patients with body mass index (BMI) between 18 and 40 kg/m2 (both inclusive). 6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening (visit 1) and baseline (visit 2). 7. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 8. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: Psychiatric Criteria: 1. Patients with history of: a. Any depressive episode with psychotic or catatonic features b. Any manic, hypomanic or mixed episode, including bipolar disorder (Type 1 or Type 2) and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode c. Bipolar depression d. Schizophrenia, schizoaffective, or other psychotic disorder e. Panic disorder, with or without agoraphobia f. Obsessive-compulsive disorder g. Bulimia or anorexia nervosa h. Any persistent neurocognitive disorder i. Any other anxiety disorder which has been the primary focus of clinical attention for the six months prior to screening, while MDD was a secondary focus of attention 2. Patients with history of treatment resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode. 3. Patients with Improvement in MADRS score of = 25% between visit 1 and visit 2. 4. Patients with post-traumatic stress disorder, active within 3 years of visit 1. 5. Patients with borderline or antisocial personality disorder or other disorder of sufficient severity to interfere with participation in this study. 6. Patients with alcohol/substance use disorder (other than nicotine or caffeine), active within 1 year of visit 1. 7. Patients with psychiatric hospitalization within current depressive episode. Psychiatric symptoms secondary to any other general medical condition. 8. Patients with clinically significant risk of suicide or harm to self or others. Risk of suicide is determined by meeting any of the following criteria: a. In the judgment of the investigator, the patient may be a significant risk for suicide as judged by the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) at visit 1 or visit 2 (e.g., The patient responded “yes ? to question 4 or question 5 on the screening CSSRS, and the most recent episode occurred within the current depressive episode). b. The patient has attempted suicide within the current depressive episode. c. MADRS Item 10 score = 5 at visit 1 or visit 2. Treatment-Related Criteria: 9. Patients with the use of drugs that are strong inhibitors of CYP2D6 (e.g., Fluoxetine, Paroxetine, Quinidine). 10. Patients with the use of drugs that are inhibitors of CYP2B6, the primary enzyme that metabolizes Bupropion (e.g., Clopidogrel, Ticlopidene, Prasugrel), or that are inducers of CYP2B6 (e.g., Ritonavir, Lopinavir, Efavirenz). 11. Patients with current use, or use within 14 days before visit 1, of monoamine oxidase inhibitors (MAOIs), or Linezolid, or intravenous Methylene Blue. 12. Patients with the use of opioids (e.g., Codeine, Oxycodone, Morphine) within 14 days before visit 1. 13. Patients having received any prohibited medications, supplements or herbal products including any antipsychotic, anticonvulsant/mood stabilizer, anxiolytic, Benzodiazepine, ADT, or ADT augmentation agent (e.g., T3 [except as treatment for thyroid condition], 2nd antidepressant, etc.) within 1 week or 5 half- lives of the medication, whichever is longer, prior to visit 2; however, 4 weeks is required for T3, 2 weeks is required for MAOIs. Lithium must be tapered and followed by a 1-week washout. The safe withdrawal from benzodiazepine treatment should be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MADRS total score from baseline to week 6.Timepoint: At Baseline or Randomization Visit (Day 0), Follow up Visit (Week 1 / Day 7±2), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 3 / Day 21±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and Serious adverse events reported during the study.Timepoint: Throughout the study.;Change in CGI-S from baseline to week 6.Timepoint: At Baseline or Randomization Visit (Day 0), Follow up Visit (Week 1 / Day 7±2), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 3 / Day 21±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2).;Change in Q-LES-Q-SF score from baseline to week 6.Timepoint: At Baseline or Randomization Visit (Day 0), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2).;Change in QIDS-SR-16 score from baseline to week 6.Timepoint: At Baseline or Randomization Visit (Day 0), Follow up Visit (Week 1 / Day 7±2), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 3 / Day 21±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2).;Change in SDS total score from baseline to week 6.Timepoint: At Baseline or Randomization Visit (Day 0), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2).;Changes in clinical laboratory parameters.Timepoint: At Screening Visit and End of the Treatment Visit (Week 6 / Day 42±2).;Clinical Global Impression of Improvement of Illness (CGI-I) at week 1, week 2, week 3, week 4 and week 6.Timepoint: At Follow up Visit (Week 1 / Day 7±2), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 3 / Day 21±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2).;Clinical response (= 50% reduction in MADRS total score) at week 1, week 2, week 3, week 4 and week 6.Timepoint: At Follow up Visit (Week 1 / Day 7±2), Follow up Visit (Week 2 / Day 14±2), Follow up Visit (Week 3 / Day 21±2), Follow up Visit (Week 4 / Day 28±2) and End of the Treatment Visit (Week 6 / Day 42±2).;Patient Global Impression-Improvement (PGI-I) at week 6.Tim | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed