Evaluating the safety and efficacy of PM011 as an antidepressant for patients with mild to moderate depression
| ISRCTN | ISRCTN79447606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79447606 |
| Secondary identifying numbers | CCRG_06_01 |
- Submission date
- 19/04/2010
- Registration date
- 29/04/2010
- Last edited
- 09/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ko Seong-Gyu
Scientific
Scientific
Center for Clinical Research and Genomics
#513 Ecologic science college
Kyung Hee university
1 Hoegi-dong
Dongdaemun-gu
Seoul
130-701
Korea, South
Study information
| Study design | Randomised double blind parallel group multi-dose placebo controlled phase IIb trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of PM011 as an antidepressant |
| Study objectives | The optimal dose of PM011 would decrease 17-item HAM-D score more than placebo control. |
| Ethics approval(s) | 1. The institutional review board (IRB) of the Catholic University of Korea, Seoul St Mary's hospital approved on the 19/02/2008 (ref: KCMC07MS274) 2. The IRB of East-West Neo Medical Centre approved on the 30/11/2007 (ref: KHNMC-OH-IRB 2007-013) 3. The IRB of Wonkwang University Sanbon Oriental Medical Centre approved on the 30/11/2007 (ref: WONSBHB IRB 2008-3) 4. The IRB of Sanji University Oriental Medical Centre approved (ref: SJ2008-050101) 5. The Catholic University of Korea, St. Vincent's hospital approved on the 21/09/2009 (ref: VC09MDMS0043) |
| Health condition(s) or problem(s) studied | Mild to moderate depression |
| Intervention | Patients are randomised to receive 1. PM011 (extract of nelumbinis semen [lotus seed]), low dose 1200mg/day (400mg pill x 3 times daily) 2. PM011, moderate dose 2400 mg/day (800 mg pill x 3 times daily) 3. PM011, high dose 4800 mg/day (1600 mg pill x 3 times daily) 4. Placebo control, consisting of corn starch and milk sugar The trial consists of screening (visit 1), run-in phase (visit 2/day -7), treatment period (visit 3/day 1, visit 4/day 15, visit 5/day 29, visit 6/day 43) and follow-up (by telephone/day 50). The run-in phase is during 1 week. In run-in phase, all participants would take placebo control. The duration of treatment is 6 weeks. The total duration of the trial including follow-up period is 9 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | PM011 (extract of nelumbinis semen [lotus seed]) |
| Primary outcome measure | 17-item Hamilton Rating Scale for Depression (HAM-D), measured at screening, run-in phase (day -7 and if more than one week since screening), days 1, 15, 29 and 43 of treatment. |
| Secondary outcome measures | 1. Montgomery-Asberg Depression Rating Scale, measured at days 1, 15, 29 and 43 2. Clinical Global Impression (CGI), measured at days 1, 15, 29 and 43 3. Brief version of World Health Organization Quality of Life Questionnaire (WHOQOL), measured at day 1 and 43 (start and end of treatment) 4. Visual Analogue Scale (VAS), measured at days 1, 15, 29 and 43 5. International Index of erectile function; male, measured at day 1 and 43 (start and end of treatment) 6. Female Sexual Function Index (FSFI); female, measured at day 1 and 43 (start and end of treatment) 7. Symptom Checklist-90-R (SCL-90-R), measured at day 1 and 43 (start and end of treatment) |
| Overall study start date | 09/07/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 136 (34 for each group) |
| Key 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 |
| Key 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). |
| Date of first enrolment | 09/07/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Center for Clinical Research and Genomics
Seoul
130-701
Korea, South
130-701
Korea, South
Sponsor information
Purimed (South Korea)
Industry
Industry
#203 A compartment of Chun-taeck building
Hwikyung-1-dong
Dongdaemun-gu
Seoul
130-091
Korea, South
Funders
Funder type
Industry
Purimed (South Korea)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
