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

NCT00621270 | Completed Phase 2

• 1 other identifier: BCI-540-CL-001
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 16

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.

Conditions

Major Depressive Disorder; Anxiety

Keywords

Major Depression Neurogenesis; Major Depressive Disorder with Concomitant Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

EXPERIMENTAL

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

Drug: BCI-540

2

EXPERIMENTAL

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

Drug: BCI-540

3

PLACEBO COMPARATOR

Placebo

Drug: BCI-540

Interventions

BCI-540 DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrainCells Inc.: lead

Study Sites (16)

Grey Nuns Hospital, Clinical Research

Edmonton, Alberta, T6L 5X8, Canada

Location

Okanagan Clinical Trials

Kelowna, British Columbia, V1Y 2H4, Canada

Location

Dr. Alexander McIntyre, Inc

Penticton, British Columbia, V2A 4M4, Canada

Location

University of British Columbia Mood Disorders Centre

Vancouver, British Columbia, V6T 2A1, Canada

Location

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

Vancouver, British Columbia, V6Z 2L4, Canada

Location

Eden Mental Health Centre

Winkler, Manitoba, R6W 1T4, Canada

Location

Sanjay Siddhartha, MD

Miramichi, New Brunswick, E1V 3G5, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Autar K. Munshi, MD

Sydney, Nova Scotia, B1S 2E8, Canada

Location

Robert Fairbairn, MD

Chatham, Ontario, N7M 5L9, Canada

Location

Providence Care Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

Robert G. Luton, MD

London, Ontario, N6A 5R9, Canada

Location

Anxiety and Mood Disorder Center

Mississauga, Ontario, L5M 4N4, Canada

Location

Ottawa Psychopharmacology Clinic

Ottawa, Ontario, K1G 4G3, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network, Dept. of Psychiatry

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

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

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 24, 2011

Record last verified: 2011-10

Locations

CA (16)