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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621270
• Other study ID #: BCI-540-CL-001
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2008
• Last updated: October 20, 2011
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2011
• Source: BrainCells Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BrainCells Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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