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

Sponsor

BrainCells Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00621270

Collaborator

(none)

115

Enrollment

Locations

Arms

Duration (Months)

7.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

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

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

Placebo

Drug: BCI-540

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

Outcome Measures

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). [Week 6]

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). [Weeks 2, 4, 6, 7 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Grey Nuns Hospital, Clinical Research	Edmonton	Alberta	Canada	T6L 5X8
2	Okanagan Clinical Trials	Kelowna	British Columbia	Canada	V1Y 2H4
3	Dr. Alexander McIntyre, Inc	Penticton	British Columbia	Canada	V2A 4M4
4	University of British Columbia Mood Disorders Centre	Vancouver	British Columbia	Canada	V6T 2A1
5	Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.	Vancouver	British Columbia	Canada	V6Z 2L4
6	Eden Mental Health Centre	Winkler	Manitoba	Canada	R6W 1T4
7	Sanjay Siddhartha, MD	Miramichi	New Brunswick	Canada	E1V 3G5
8	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 2E2
9	Autar K. Munshi, MD	Sydney	Nova Scotia	Canada	B1S 2E8
10	Robert Fairbairn, MD	Chatham	Ontario	Canada	N7M 5L9
11	Providence Care Mental Health Services	Kingston	Ontario	Canada	K7L 4X3
12	Robert G. Luton, MD	London	Ontario	Canada	N6A 5R9
13	Anxiety and Mood Disorder Center	Mississauga	Ontario	Canada	L5M 4N4
14	Ottawa Psychopharmacology Clinic	Ottawa	Ontario	Canada	K1G 4G3
15	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
16	University Health Network, Dept. of Psychiatry	Toronto	Ontario	Canada	M5G 2C4