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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BrainCells Inc.
ClinicalTrials.gov Identifier:
NCT00621270
First received: February 11, 2008
Last updated: October 20, 2011
Last verified: October 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by BrainCells Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 115
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
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
Placebo
Drug: BCI-540
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621270

Locations
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
University Health Network, Dept. of Psychiatry
Toronto, Ontario, Canada, M5G 2C4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
BrainCells Inc.
Investigators
Study Chair: Allan H. Young, MB ChB, MPhil, PhD, FRCPsych Institute of Mental Health, Dept. of Psychiatry, University of British Columbia
  More Information

No publications provided

Responsible Party: BrainCells Inc.
ClinicalTrials.gov Identifier: NCT00621270     History of Changes
Other Study ID Numbers: BCI-540-CL-001
Study First Received: February 11, 2008
Last Updated: October 20, 2011
Health Authority: Canada: Health Canada

Keywords provided by BrainCells Inc.:
Major Depression Neurogenesis
Major Depressive Disorder with Concomitant Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mental Disorders
Pathologic Processes
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014