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Safety and Effectiveness Study of BCI-540 Versus Placebo in the Treatment of Major Depressive Disorder With Concomitant Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621270
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : October 24, 2011
Information provided by (Responsible Party):
BrainCells Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Anxiety Drug: BCI-540 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
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

Experimental: 2
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

Placebo Comparator: 3
Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo

Primary Outcome Measures :
  1. Co-primary outcome measures will be the change from Baseline to Week 6 on the total score of the Inventory of Depressive Symptomatology-Clinician Version (IDS-C30) and the Hamilton Rating Scale for Anxiety (HAM-A). [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. The safety, tolerability and side effect profile of BCI-540 will also be measured by adverse events, clinical laboratory values, electrocardiograms, vital signs, and the Physician Withdrawal Checklist (PWC). [ Time Frame: Weeks 2, 4, 6, 7 and 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient meets the DSM IV-TR criteria for Major Depressive Disorder (MDD) as determined by the Mini-International Neuropsychiatric Interview (MINI) and psychiatric evaluation.
  • The patient has a score of 20 or more on the HAM D17 scale, a score of 30 or more on the IDS-C30 and a score of 15 or more on the HAM-A scale at the Screening and Baseline visits.
  • The patient has a score of at least 2 on items 1 and 2 of the HAM-A scale at the Screening and Baseline visits.
  • The patient has a Clinical Global Impression of Severity (CGI S) rating of 4 or higher at the Screening and Baseline visits.
  • The patient has recurrent MDD.
  • The patient did not respond to at least one but no more than five adequate antidepressant trials during the current MDD episode.
  • The patient is living with another adult or has daily contact with an adult and contact information for the patient and this adult is available to the investigator.
  • Female patients of childbearing potential must be using a reliable, medically acceptable form of contraception for at least 30 days prior to the screening visit and must agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

  • The patient has a decrease of 20% or more in HAM D17 total score or HAM-A total score from the screening visit to the Baseline visit.
  • The patient represents significant risk of suicide in the opinion of the investigator at the screening or Baseline visit.
  • The patient has any other psychiatric Axis-I disorder (except GAD) as a principal diagnosis within 6 months of Screening.
  • The patient has a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation.
  • The patient has a history of alcohol or substance (excluding nicotine or caffeine) abuse within 3 months of the screening visit, alcohol or substance dependence within 6 months of Screening.
  • The patient shows current evidence of substance abuse confirmed by results of a urine drug screen.
  • The patient has used an antidepressant medication (SSRI/SNRI or any other antidepressant medication, including MAOIs), within 1 week of Baseline(fluoxetine within 5 weeks).
  • The patient has a history of low RBC count, low hemoglobin, low WBC count, low platelets, or low reticulocyte counts of any aetiology other than that known to be related to blood loss, iron deficiency, or pregnancy.
  • The patient shows current evidence of macrocytosis, low RBC count, low haemoglobin, low WBC count, or low platelet count of any aetiology.
  • The patient will use drugs during the study (including follow-up) that are known to be related to agranulocytosis and/or aplastic anaemia.
  • The patient will receive interpersonal therapy and/or short-term (brief) dynamic therapy during the study.
  • The patient received ECT within 3 months of Screening.
  • The patient received depot antipsychotic therapy at any time.
  • The patient has used any antipsychotic or anxiolytic medications within 1 week of Screening.
  • The patient has used any drugs with known psychotropic properties or any non-psychotropic drugs with potential CNS effects within one week or 5-half lives (whichever is longer) of Screening.
  • The patient has a clinically significant cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurological, malignancy, metabolic, psychiatric or other condition that might be detrimental to the patient if he or she participates in the study.
  • The patient has a known hypersensitivity to any cholinesterase inhibitors or cholinergic agonist drugs.
  • The patient is a pregnant or lactating woman.
  • The patient has a history of seizures.
  • The patient has clinically significant abnormalities on screening physical examination, ECG, serum chemistry, urinalysis tests, including thyroid stimulating hormone levels, as judged by the investigator.
  • The patient has a known positivity for human immunodeficiency virus, hepatitis B surface-antigen, or hepatitis C virus antibody.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621270

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Canada, Alberta
Grey Nuns Hospital, Clinical Research
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y 2H4
Dr. Alexander McIntyre, Inc
Penticton, British Columbia, Canada, V2A 4M4
University of British Columbia Mood Disorders Centre
Vancouver, British Columbia, Canada, V6T 2A1
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
Robert Fairbairn, MD
Chatham, Ontario, Canada, N7M 5L9
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Robert G. Luton, MD
London, Ontario, Canada, N6A 5R9
Anxiety and Mood Disorder Center
Mississauga, Ontario, Canada, L5M 4N4
Ottawa Psychopharmacology Clinic
Ottawa, Ontario, Canada, K1G 4G3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network, Dept. of Psychiatry
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
BrainCells Inc.
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Study Chair: Allan H. Young, MB ChB, MPhil, PhD, FRCPsych Institute of Mental Health, Dept. of Psychiatry, University of British Columbia
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Responsible Party: BrainCells Inc. Identifier: NCT00621270    
Other Study ID Numbers: BCI-540-CL-001
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: October 24, 2011
Last Verified: October 2011
Keywords provided by BrainCells Inc.:
Major Depression Neurogenesis
Major Depressive Disorder with Concomitant Anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mental Disorders
Mood Disorders
Behavioral Symptoms