Evaluating the safety and efficacy of PM011 as an antidepressant for patients with mild to moderate depressio

Completed

• Conditions: Mild to moderate depression; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN79447606
• Lead Sponsor: Purimed (South Korea)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Patient aged 18 to 65 male or female
2. Patient diagnosed as major depressive disorder by DSM-?W, had major depressive episode during last 30 days (before screening day)
3. 17-item Hamilton Rating Scale for Depression (HAM-D) scored 18 to 25
4. Patient given written informed consent form
5. Patient given written informed consent form of genetic study

Exclusion Criteria

1. Woman who is pregnant, breast-feeding or not using appropriate contraception
2. Patient who has risk committing suicide, above 2 on the HAM-D suicide item (item #3)
3. Patient who has neurologic or psychiatric disorder except depression (schizophrenia, bipolar disorder, epilepsy, drug abuse, alcohol abuse, panic disorder or agitation that needs treatment etc)
4. Seriously irritable patient
5. Patient who has clinically significant liver disease or liver enzyme levels elevated to at least twice the upper normal limit
6. Patient who has chronic renal failure or over 1.5 folds blood creatinine level compared with the upper normal limit
7. Patient whose elevated laboratory test level that cause affective disorder (ex. thyroid disorder)
8. Patient who is not responder of anti-depressant or has history of non-response
9. Patient that had participated in another clinical trial in 1 month before screening day
10. Patient who is hypersensitive or has allergy about intervention
11. Patient who has digestive disease that could interfere with drug absorption
12. Patient who is intellectual and developmental disabled or emotionally irritable
13. Patient whose HAM-D score decreased more than 20% during placebo run-in phase
14. Patient who is taking hormone therapy or has history of hormone therapy
15. Patient who has received drug therapy or psychotherapy that meets exclusion criteria during clinical trial
16. Patient who has stressful life events or acute stress reaction (stressful life event and mental health score over 200 points at screening).

Study & Design

• Study Type: Interventional
• Study Design: Not specified