Anxiety Clinical Trial
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
Verified date | October 2011 |
Source | BrainCells Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 115 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Robert Fairbairn, MD | Chatham | Ontario |
Canada | Grey Nuns Hospital, Clinical Research | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Okanagan Clinical Trials | Kelowna | British Columbia |
Canada | Providence Care Mental Health Services | Kingston | Ontario |
Canada | Robert G. Luton, MD | London | Ontario |
Canada | Sanjay Siddhartha, MD | Miramichi | New Brunswick |
Canada | Anxiety and Mood Disorder Center | Mississauga | Ontario |
Canada | Ottawa Psychopharmacology Clinic | Ottawa | Ontario |
Canada | Dr. Alexander McIntyre, Inc | Penticton | British Columbia |
Canada | Autar K. Munshi, MD | Sydney | Nova Scotia |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network, Dept. of Psychiatry | Toronto | Ontario |
Canada | Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc. | Vancouver | British Columbia |
Canada | University of British Columbia Mood Disorders Centre | Vancouver | British Columbia |
Canada | Eden Mental Health Centre | Winkler | Manitoba |
Lead Sponsor | Collaborator |
---|---|
BrainCells Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Week 6 | No | |
Secondary | 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). | Weeks 2, 4, 6, 7 and 12 | Yes |
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