Condition category
Mental and Behavioural Disorders
Date applied
19/04/2010
Date assigned
29/04/2010
Last edited
09/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ko Seong-Gyu

ORCID ID

Contact details

Center for Clinical Research and Genomics
#513 Ecologic science college
Kyung Hee university
1 Hoegi-dong
Dongdaemun-gu
Seoul
130-701
Korea
South

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 measures

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

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

Sponsor information

Organisation

Purimed (South Korea)

Sponsor details

#203 A compartment of Chun-taeck building
Hwikyung-1-dong
Dongdaemun-gu
Seoul
130-091
Korea
South

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes