A study to assess the efficacy and safety of combination of Dextromethorphan and Bupropion Tablets in patients with depression.

Phase 3

Completed

• Conditions: Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

• Registration Number: CTRI/2023/06/053474
• Lead Sponsor: Exemed Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-09
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 212

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in MADRS total score from baseline to week 6.Timepoint: At Baseline or Randomization Visit (Day 0), <br/ ><br>Follow up Visit (Week 1 / Day 7±2), <br/ ><br>Follow up Visit (Week 2 / Day 14±2), <br/ ><br>Follow up Visit (Week 3 / Day 21±2), <br/ ><br>Follow up Visit (Week 4 / Day 28±2) and <br/ ><br>End of the Treatment Visit (Week 6 / Day 42±2).