Major Depressive DisorderPhase 2NAPANCT01606384
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
A Phase 2 study testing VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) in people with Major Depressive Disorder, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective: To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder. Secondary Objectives: To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Aug 2007
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria.
Who cannot join
- Outpatients unwilling to be hospitalized a total of 6 nights and 8 days.
- Total score of less than 21 (<21) on the 17-item Hamilton Depression Rating Scale (HAM-D) at Visit 1 (Day -7) or Visit 5 (Day -1).
- Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.
- Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.
- Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (MAOI) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder
Primary Objective:
- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder.
- To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder.
- To evaluate plasma concentrations of SSR149415.
Read the detailed description
The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free, screening and baseline period. Segment B was a 4-week, double-blind period. After the last dose of double-blind study medication in Segment B, all patients had to enter Segment C, a 1-week drug-free, follow-up period.
The total study duration for one patient participating in all segments of the study was 6 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415), 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.
VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)Drug
Pharmaceutical form: Capsule Route of administration: oral
PlaceboDrug
Pharmaceutical form: Capsule Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Twice daily Receives: Drug: Placebo |
| SSR149415 - 100mg | Experimental | Twice daily Receives: Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) |
| SSR149415 - 250mg | Experimental | Twice daily Receives: Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
Measured: 4 weeks
Secondary outcomes (4)
Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
Measured: 4 weeks
Number of patients with adverse events
Measured: Up to 6 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Measured: Baseline, 4 weeks
Changes Clinical Global Impression (CGI) Severity and Improvement scores
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606384
- Sponsor's protocol ID
- PDY5467
- Acronym
- NAPA
- Status last verified
- May 2012
- First submitted
- 23 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
Publications
Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.
PubMed 23146246
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01606384
- Acronym / sponsor ID
- NAPA / PDY5467
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 25 May 2012 (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.
Primary Objective:
- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder.
- To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder.
- To evaluate plasma concentrations of SSR149415.
Detailed description
The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free, screening and baseline period. Segment B was a 4-week, double-blind period. After the last dose of double-blind study medication in Segment B, all patients had to enter Segment C, a 1-week drug-free, follow-up period.
The total study duration for one patient participating in all segments of the study was 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTwice daily |
| SSR149415 - 100mg | Experimental | Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)Twice daily |
| SSR149415 - 250mg | Experimental | Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)Twice daily |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria.
Key exclusion criteria (6 listed)
- Outpatients unwilling to be hospitalized a total of 6 nights and 8 days.
- Total score of less than 21 (<21) on the 17-item Hamilton Depression Rating Scale (HAM-D) at Visit 1 (Day -7) or Visit 5 (Day -1).
- Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.
- Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.
- Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (MAOI) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications
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 |
|---|---|---|
| VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)Pharmaceutical form: Capsule Route of administration: oral | Drug | SSR149415 - 100mg, SSR149415 - 250mg |
| PlaceboPharmaceutical form: Capsule Route of administration: Oral | Drug | Placebo |
Primary outcome
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
Time frame: 4 weeks
4 secondary outcomes
Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
Time frame: 4 weeks
Number of patients with adverse events
Time frame: Up to 6 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Time frame: Baseline, 4 weeks
Changes Clinical Global Impression (CGI) Severity and Improvement scores
Time frame: Baseline, 4 weeks
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 25 May 2012.
- Derived from this study: PubMed 23146246Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) in people with Major Depressive Disorder, run by Sanofi at 1 site in United States.
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 1 inclusion and 6 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 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606384, which also lists 1 linked publication.
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 25 May 2012.