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Sponsored by: |
BrainCells Inc. |
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Information provided by: | BrainCells Inc. |
ClinicalTrials.gov Identifier: | NCT00621270 |
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 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
BCI-540 80 mg once a day (q.d.)
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Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
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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
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Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
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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.
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pamela C Wedel | 858-812-7640 | pwedel@braincellsinc.com |
Canada, Alberta | |
Grey Nuns Hospital, Clinical Research | Recruiting |
Edmonton, Alberta, Canada, T6L 5X8 | |
Principal Investigator: Pratap Chokka, MD | |
Canada, British Columbia | |
University of British Columbia Mood Disorders Centre | Recruiting |
Vancouver, British Columbia, Canada, V6T 2A1 | |
Principal Investigator: Raymond Lam, MD | |
Okanagan Clinical Trials | Recruiting |
Kelowna, British Columbia, Canada, V1Y 2H4 | |
Principal Investigator: Paul Latimer, MD | |
Dr. Alexander McIntyre, Inc | Recruiting |
Penticton, British Columbia, Canada, V2A 4M4 | |
Principal Investigator: Alexander McIntyre, MD | |
Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc. | Recruiting |
Vancouver, British Columbia, Canada, V6Z 2L4 | |
Principal Investigator: Diane McIntosh, MD | |
Sub-Investigator: Kevin Kjernisted, MD | |
Canada, Manitoba | |
Eden Mental Health Centre | Recruiting |
Winkler, Manitoba, Canada, R6W 1T4 | |
Principal Investigator: Larry J Klassen, MD | |
Canada, New Brunswick | |
Sanjay Siddhartha, MD | Recruiting |
Miramichi, New Brunswick, Canada, E1V 3G5 | |
Principal Investigator: Sanjay Siddhartha, MD | |
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Centre | Recruiting |
Halifax, Nova Scotia, Canada, B3H 2E2 | |
Principal Investigator: Claire O'Donovan, MD | |
Autar K. Munshi, MD | Recruiting |
Sydney, Nova Scotia, Canada, B1S 2E8 | |
Principal Investigator: Autar K Munshi, MD | |
Canada, Ontario | |
Sleep and Neuropsychiatry Institute | Recruiting |
Scarborough, Ontario, Canada, M1S 1T7 | |
Principal Investigator: Alan D Lowe, MD | |
Providence Care Mental Health Services | Recruiting |
Kingston, Ontario, Canada, K7L 4X3 | |
Principal Investigator: Roumen Milev, MD | |
University Health Network, Dept. of Psychiatry | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Principal Investigator: Sidney Kennedy, MD | |
Sub-Investigator: Roger McIntyre, MD | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Principal Investigator: Ayal Schaffer, MD | |
Robert Fairbairn, MD | Recruiting |
Chatham, Ontario, Canada, N7M 5L9 | |
Principal Investigator: Robert Fairbairn, MD | |
Anxiety and Mood Disorder Center | Recruiting |
Mississauga, Ontario, Canada, L5M 4N4 | |
Principal Investigator: Nabil Philips, MD | |
Robert Luton, MD | Recruiting |
London, Ontario, Canada, N6A 5R9 | |
Principal Investigator: Robert Luton, MD | |
Satpal S. Girgla, MD | Recruiting |
Oakville, Ontario, Canada, L6J 7W | |
Principal Investigator: Satpal S Girgla, MD | |
Robert G. Luton, MD | Recruiting |
London, Ontario, Canada, N6A 5R9 | |
Principal Investigator: Robert G Luton, MD | |
Ottawa Psychopharmacology Clinic | Recruiting |
Ottawa, Ontario, Canada, K1G 4G3 | |
Principal Investigator: David Bakish, MD |
Study Chair: | Allan H. Young, MB ChB, MPhil, PhD, FRCPsych | Institute of Mental Health, Dept. of Psychiatry, University of British Columbia |
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: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00621270 |
Health Authority: | Canada: Health Canada |
Major Depression Neurogenesis Major Depressive Disorder with Concomitant Anxiety |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |