Generic depression patch tested against brand in small study
NCT ID NCT06607744
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a generic selegiline skin patch works the same as the brand-name EMSAM patch. Twelve healthy adults wore both patches to measure how much drug got into their blood and to check for skin irritation. The goal was to see if the generic version is a safe and effective alternative.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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12 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Local subjects participate in the Hospital Ampang, Malaysia
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject age between 18 to 55 years old with adequate contraception but without taking oral contraceptives. 2. Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m². 3. Subject is able to complete the clinical study including the follow-up. 4. Subject is capable of providing written informed consent. 5. Subjects are able and willing to follow the requirements of the study and wearing patches. Exclusion Criteria: 1. Breastfeeding female. 2. Pregnancy test positive female. 3. At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50- 90 mmHg or orthostatic hypotension. 4. At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm. 5. Clinically significant ECG abnormalities (PQ interval \> 0.2 s, Duration of the QRS complex \> 0.1 s, AV block). 6. QTc \> 450 ms for male and \> 460 ms for female. 7. A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant. 8. Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history. 9. Family history of sudden cardiac death or pheochromocytoma. 10. Clinically significant physical examination finding or psychiatric unstable conditions or psychiatric illness requiring treatment. 11. Clinically significant laboratory abnormalities. 12. Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening. 13. Total bilirubin \> 1.25 x upper limit of normal, ALT/AST \> 1.5 x upper limit of normal. 14. Hepatitis B, Hepatitis C or HIV positive. 15. Urine DOA test positive. 16. Breath alcohol test positive. 17. Any smoker with tobacco or electronic tobacco products. 18. A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint \[285 mL\] of beer, 1 glass \[125 mL\] of wine, or 1 shot \[25 mL\] of spirit). 19. Taking selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI) or cough or cold medicine (e.g., dextromethorphan, pseudoephedrine) or using carbamazepine or oxcarbazepine, or using meperidine and analgesic agents such as tramadol, methadone, and propoxyphene, or using sympathomimetic agents. 20. Unable to refrain from taking any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator. 21. Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent taking.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Ampang
Ampang, Selangor, 68000, Malaysia
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Sarawak General Hospital
Samoran, Sarawak, 94300, Malaysia
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Other studies related to the condition(s) this trial covers.
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