NCT01606384

Brief 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.
  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 major-depressive-disorder

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

May 23, 2012

Last Update Submit

May 24, 2012

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing

    4 weeks

Secondary Outcomes (4)

  • Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing

    4 weeks

  • Number of patients with adverse events

    Up to 6 weeks

  • Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores

    Baseline, 4 weeks

  • Changes Clinical Global Impression (CGI) Severity and Improvement scores

    Baseline, 4 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Twice daily

Drug: Placebo

SSR149415 - 100mg

EXPERIMENTAL

Twice daily

Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)

SSR149415 - 250mg

EXPERIMENTAL

Twice daily

Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)

Interventions

VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)DRUG

Pharmaceutical form: Capsule Route of administration: oral

SSR149415 - 100mgSSR149415 - 250mg
PlaceboDRUG

Pharmaceutical form: Capsule Route of administration: Oral

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Location

Related Publications (1)

  • 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.

    PMID: 23146246DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

1-(5-chloro-1-((2,4-dimethoxyphenyl)sulfonyl)-3-(2-methoxyphenyl)-2-oxo-2,3-dihydro-1H-indol-3-yl)-4-hydroxy-N,N-dimethyl-2-pyrrolidinecarboxamide

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

US(1)