Major Depressive DisorderPhase 2NCT00659347
Efficacy and Safety of DOV 21,947 in the Treatment of Major Depressive Disorder
A Phase 2 study testing DOV 21, 947 in people with Major Depressive Disorder, run by DOV Pharmaceutical, Inc. at 26 sites in 3 countries.
Trial summary
The primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- DOV 21, 947
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Mar 2008to Dec 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between 18 and 65 years of age (inclusive).
- Either outpatients or inpatients diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, see Appendix 3) and MINI International Neuropsychiatric Interview (MINI).
- Patients with recurrent depressive episode of at least 2 months in duration. Patients must have previously responded (significant clinical improvement judged by the Principal Investigator) to at least one antidepressant treatment.
- HAMD-17 total score * 22 with a severity score of at least 2 on Item 1 at the Placebo Run-In Visit and the Baseline/Day 1 Visit.
- HAMD-17 score reduction ≤ 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit.
- HAM-A total score < 17 at the Screening Visit.
Who cannot join
- Patients with a HAMD-17 total score reduction of more than 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit (placebo responders).
- Patients with a medical history of MDD that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (MAO) inhibitor.
- Patients who are known to be antidepressant treatment-resistant. Patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., TCA, SSRI, SNRI, MAO-I, etc). Failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the Principal Investigator's discretion.
- Patients with a medical history of MDD who consistently did not respond significantly to electroconvulsive shock therapy (ECT) or had ECT within a year prior to the Screening Visit regardless of outcome.
- Patients with psychotic depression
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Romania12 sites
SC Corpores Sana Medical SRL
Bucharest, Bucharest, 010604
Spitalul Clinic "Colentina", Ambulator Specialitate, Sectia Psihiatrie
Bucharest, Bucharest, 020125
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", pavilion III
Bucharest, Bucharest, 041915
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion IV
Bucharest, Bucharest, 041915
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Pavilion X
Bucharest, Bucharest, 041915
Spitalul Clinic de Psihiatrie "Socola"
Lasi, Lasi, 700282
Spitalul Universitar de Psihiatrie "Socola"
Lasi
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, Bihor County, 410154
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, Piatra Neamt, 610136
Spitalul Judetean Arges
Piteşti, Argeş, 110084
Cabinetul Medical Lorentina 2102 S.R.L.
Targoviste, Dâmbovița County, 130081
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Targu Mures, 540139
United States10 sites
Brooklyn Medical Institute
Brooklyn, New York, 11223
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
CRI Worldwide, LLC
Clementon, New Jersey, 08021
Social Psychiatry Research Institute
New York, New York, 10021
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Princeton Medical Institute
Princeton, New Jersey, 08540
Scranton Medical Institutes
Scranton, Pennsylvania, 18503
Future Care Studies
Springfield, Massachusetts, 01103
Richmond Behavorial Associates
Staten Island, New York, 10312
Serbia4 sites
Institut za mentalno zdravlje Palmoticeva 37
Belgrade, 11000
Institut za psihijatriju KCS
Belgrade, 11000
Klinika za neurologiju i psihijatriju
Kragujevac, 34000
Klinika za psihijatriju Vojnomedicinske Akademije
Velgrade, 1100
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder
The primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels.
Read the detailed description
DOV 21,947 is an investigational drug that is being developed for the treatment of depression. The purpose of this study is to evaluate the safety and effectiveness of a flexible dosing schedule of DOV 21,947 (25 mg twice daily for two weeks, then 50 mg twice daily for four weeks as compared to placebo) in the treatment of major depressive disorder. Information about any side effects that may occur will also be collected.
The efficacy evaluation will be based on the change in the total MADRS and HAMD-17 scores from randomization to week 9 .The secondary objective is to determine if DOV 21,947 improves the quality of life for patients with MDD as compared to placebo
- Conditions
- Major Depressive Disorder
- Being tested
- DOV 21, 947, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOV 21, 947Drug
Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks
PlaceboDrug
Capsules,25 mg,BID,6weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: DOV 21, 947 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the change in tot al score of MADRS scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DOV Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nuoyu Huang, MD/PhD, Study director, DOV Pharmaceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659347
- Sponsor's protocol ID
- DOV 947-010
- Status last verified
- Dec 2008
- First submitted
- 9 Apr 2008
- Last updated
- 5 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00659347
- Acronym / sponsor ID
- DOV 947-010
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DOV Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Apr 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 primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels.
Detailed description
DOV 21,947 is an investigational drug that is being developed for the treatment of depression. The purpose of this study is to evaluate the safety and effectiveness of a flexible dosing schedule of DOV 21,947 (25 mg twice daily for two weeks, then 50 mg twice daily for four weeks as compared to placebo) in the treatment of major depressive disorder. Information about any side effects that may occur will also be collected.
The efficacy evaluation will be based on the change in the total MADRS and HAMD-17 scores from randomization to week 9 .The secondary objective is to determine if DOV 21,947 improves the quality of life for patients with MDD as compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DOV 21, 947 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females between 18 and 65 years of age (inclusive).
- Either outpatients or inpatients diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, see Appendix 3) and MINI International Neuropsychiatric Interview (MINI).
- Patients with recurrent depressive episode of at least 2 months in duration. Patients must have previously responded (significant clinical improvement judged by the Principal Investigator) to at least one antidepressant treatment.
- HAMD-17 total score * 22 with a severity score of at least 2 on Item 1 at the Placebo Run-In Visit and the Baseline/Day 1 Visit.
- HAMD-17 score reduction ≤ 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit.
Key exclusion criteria (5 listed)
- Patients with a HAMD-17 total score reduction of more than 15% between the Placebo Run-In Visit and the Baseline/Day 1 Visit (placebo responders).
- Patients with a medical history of MDD that consistently did not respond significantly to an adequate treatment regimen of a monoamine oxidase (MAO) inhibitor.
- Patients who are known to be antidepressant treatment-resistant. Patients are defined as treatment-resistant if in the past they have failed adequate antidepressant treatments (dose level approved in the product labeling and was administered for at least 4 weeks) from two or more different pharmacological classes (e.g., TCA, SSRI, SNRI, MAO-I, etc). Failure to respond to an adequate antidepressant treatment is defined as the absence of at least a 50% improvement in symptoms by patient report or documented history, or lack of significant clinical improvement at the Principal Investigator's discretion.
- Patients with a medical history of MDD who consistently did not respond significantly to electroconvulsive shock therapy (ECT) or had ECT within a year prior to the Screening Visit regardless of outcome.
- Patients with psychotic depression
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 |
|---|---|---|
| DOV 21, 947Capsules, 25 mg, 2 capsules (1 Active/1 Placebo) BID, 2 weeks Capsules, 25 mg, 2 capsules (2 Active) BID, 2 weeks | Drug | 1 |
| PlaceboCapsules,25 mg,BID,6weeks | Drug | 2 |
Primary outcome
The primary outcome measure will be the change in tot al score of MADRS scale.
Time frame: 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2008.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Nuoyu Huang, MD/PhD study director
DOV Pharmaceutical, Inc.
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOV 21, 947 in people with Major Depressive Disorder, run by DOV Pharmaceutical, Inc. at 26 sites in 3 countries.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Romania, United States, Serbia. 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 was stopped early. Results are not available in the source record.
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?
The primary outcome measure will be the change in tot al score of MADRS scale. (time frame: 6 weeks). 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 5 Dec 2008.