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

NCT ID: NCT00621270

Last Updated: 2011-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-10-31

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.

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.

Conditions

Major Depressive Disorder; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

BCI-540 80 mg once a day (q.d.)

Group Type: EXPERIMENTAL

BCI-540

Intervention Type: DRUG

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

2

BCI-540 80 mg three times a day (t.i.d.)

Group Type: EXPERIMENTAL

BCI-540

Intervention Type: DRUG

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

3

Placebo

Group Type: PLACEBO_COMPARATOR

BCI-540

Intervention Type: DRUG

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

Interventions

BCI-540

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrainCells Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan H. Young, MB ChB, MPhil, PhD, FRCPsych

Role: STUDY_CHAIR

Institute of Mental Health, Dept. of Psychiatry, University of British Columbia

Locations

Grey Nuns Hospital, Clinical Research

Edmonton, Alberta, Canada

Okanagan Clinical Trials

Kelowna, British Columbia, Canada

Dr. Alexander McIntyre, Inc

Penticton, British Columbia, Canada

University of British Columbia Mood Disorders Centre

Vancouver, British Columbia, Canada

Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.

Vancouver, British Columbia, Canada

Eden Mental Health Centre

Winkler, Manitoba, Canada

Sanjay Siddhartha, MD

Miramichi, New Brunswick, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Autar K. Munshi, MD

Sydney, Nova Scotia, Canada

Robert Fairbairn, MD

Chatham, Ontario, Canada

Providence Care Mental Health Services

Kingston, Ontario, Canada

Robert G. Luton, MD

London, Ontario, Canada

Anxiety and Mood Disorder Center

Mississauga, Ontario, Canada

Ottawa Psychopharmacology Clinic

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network, Dept. of Psychiatry

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

BCI-540-CL-001

Identifier Type: -

Identifier Source: org_study_id