Major Depressive DisorderPhase 2NCT00621270
Safety and Effectiveness Study of BCI-540 Versus Placebo in the Treatment of Major Depressive Disorder With Concomitant Anxiety
A Phase 2 study testing BCI-540 in people with Major Depressive Disorder and Anxiety, run by BrainCells Inc. at 16 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Major Depressive Disorder, Anxiety
- What is being tested?
- BCI-540
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 16 sitesCanada
- Study dates
- Jan 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Canada16 sites
Robert Fairbairn, MD
Chatham, Ontario, N7M 5L9
Grey Nuns Hospital, Clinical Research
Edmonton, Alberta, T6L 5X8
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2E2
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 2H4
Providence Care Mental Health Services
Kingston, Ontario, K7L 4X3
Robert G. Luton, MD
London, Ontario, N6A 5R9
Sanjay Siddhartha, MD
Miramichi, New Brunswick, E1V 3G5
Anxiety and Mood Disorder Center
Mississauga, Ontario, L5M 4N4
Ottawa Psychopharmacology Clinic
Ottawa, Ontario, K1G 4G3
Dr. Alexander McIntyre, Inc
Penticton, British Columbia, V2A 4M4
Autar K. Munshi, MD
Sydney, Nova Scotia, B1S 2E8
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network, Dept. of Psychiatry
Toronto, Ontario, M5G 2C4
University of British Columbia Mood Disorders Centre
Vancouver, British Columbia, V6T 2A1
Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
Vancouver, British Columbia, V6Z 2L4
Eden Mental Health Centre
Winkler, Manitoba, R6W 1T4
About this study
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
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.
Read the 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
- Being tested
- BCI-540
- Keywords
- Major Depression Neurogenesis, Major Depressive Disorder with Concomitant Anxiety
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI-540Drug
BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BCI-540 80 mg once a day (q.d.) Receives: Drug: BCI-540 |
| 2 | Experimental | BCI-540 80 mg three times a day (t.i.d.) Receives: Drug: BCI-540 |
| 3 | Placebo comparator | Placebo Receives: Drug: BCI-540 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Weeks 2, 4, 6, 7 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainCells Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan H. Young, MB ChB, MPhil, PhD, FRCPsych, Study chair, Institute of Mental Health, Dept. of Psychiatry, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621270
- Sponsor's protocol ID
- BCI-540-CL-001
- Status last verified
- Oct 2011
- First submitted
- 11 Feb 2008
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00621270
- Acronym / sponsor ID
- BCI-540-CL-001
- Conditions
- Major Depressive Disorder, Anxiety
- Keywords
- Major Depression Neurogenesis, Major Depressive Disorder with Concomitant Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- BrainCells Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BCI-540BCI-540 80 mg once a day (q.d.) |
| 2 | Experimental | Drug: BCI-540BCI-540 80 mg three times a day (t.i.d.) |
| 3 | Placebo comparator | Drug: BCI-540Placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCI-540BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo | Drug | 1, 2, 3 |
Primary outcome
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).
Time frame: Week 6
1 secondary outcome
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).
Time frame: Weeks 2, 4, 6, 7 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan H. Young, MB ChB, MPhil, PhD, FRCPsych study chair
Institute of Mental Health, Dept. of Psychiatry, University of British Columbia
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCI-540 in people with Major Depressive Disorder and Anxiety, run by BrainCells Inc. at 16 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2011.