Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCRG_06_01
Study information
Scientific title
A randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of PM011 as an antidepressant
Acronym
Study hypothesis
The optimal dose of PM011 would decrease 17-item HAM-D score more than placebo control.
Ethics approval
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)
Study design
Randomised double blind parallel group multi-dose placebo controlled phase IIb trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II/III
Drug names
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 trial start date
09/07/2008
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
136 (34 for each group)
Participant 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).
Recruitment start date
09/07/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Korea, South
Trial participating centre
Center for Clinical Research and Genomics
Seoul
130-701
Korea, South
Funders
Funder type
Industry
Funder name
Purimed (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list