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| Sponsor: | BrainCells Inc. |
|---|---|
| Information provided by: | BrainCells Inc. |
| ClinicalTrials.gov Identifier: | NCT00621270 |
Purpose
The purpose of this study is to determine whether BCI-540 80 mg given once daily (q.d.) or three times daily (t.i.d.) is effective in the treatment of major depression with concomitant anxiety.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder Anxiety |
Drug: BCI-540 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A 6-Week Randomised Double-Blind, Placebo-Controlled Study of BCI-540 80 mg q.d. and 80 mg t.i.d. in the Treatment of Adults With Major Depressive Disorder and Concomitant Anxiety |
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
BCI-540 80 mg once a day (q.d.)
|
Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
|
|
2: Experimental
BCI-540 80 mg three times a day (t.i.d.)
|
Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
|
|
3: Placebo Comparator
Placebo
|
Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
|
BCI-540 has been shown to be neurogenic in the Sponsor's in vitro neural stem cell analyses and in vivo animal models of depression and anxiety. These observations and the recent findings linking hippocampal function and neurogenesis to mood disorders support the evaluation of the efficacy, safety, and tolerability of BCI-540 in patients with major depressive disorder with concomitant anxiety.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Alberta | |
| Grey Nuns Hospital, Clinical Research | |
| Edmonton, Alberta, Canada, T6L 5X8 | |
| Canada, British Columbia | |
| University of British Columbia Mood Disorders Centre | |
| Vancouver, British Columbia, Canada, V6T 2A1 | |
| Okanagan Clinical Trials | |
| Kelowna, British Columbia, Canada, V1Y 2H4 | |
| Dr. Alexander McIntyre, Inc | |
| Penticton, British Columbia, Canada, V2A 4M4 | |
| Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc. | |
| Vancouver, British Columbia, Canada, V6Z 2L4 | |
| Canada, Manitoba | |
| Eden Mental Health Centre | |
| Winkler, Manitoba, Canada, R6W 1T4 | |
| Canada, New Brunswick | |
| Sanjay Siddhartha, MD | |
| Miramichi, New Brunswick, Canada, E1V 3G5 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 2E2 | |
| Autar K. Munshi, MD | |
| Sydney, Nova Scotia, Canada, B1S 2E8 | |
| Canada, Ontario | |
| Ottawa Psychopharmacology Clinic | |
| Ottawa, Ontario, Canada, K1G 4G3 | |
| Providence Care Mental Health Services | |
| Kingston, Ontario, Canada, K7L 4X3 | |
| University Health Network, Dept. of Psychiatry | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Robert G. Luton, MD | |
| London, Ontario, Canada, N6A 5R9 | |
| Robert Fairbairn, MD | |
| Chatham, Ontario, Canada, N7M 5L9 | |
| Anxiety and Mood Disorder Center | |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Study Chair: | Allan H. Young, MB ChB, MPhil, PhD, FRCPsych | Institute of Mental Health, Dept. of Psychiatry, University of British Columbia |
More Information
| Responsible Party: | BrainCells Inc. ( Carrolee Barlow, MD, PhD, Chief Scientific Officer ) |
| Study ID Numbers: | BCI-540-CL-001 |
| Study First Received: | February 11, 2008 |
| Last Updated: | October 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00621270 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Major Depression Neurogenesis Major Depressive Disorder with Concomitant Anxiety |
|
Pathologic Processes Disease Depression Mental Disorders |
Mood Disorders Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |