Clinical trial NCT01469377: Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Depression
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2011-11-10
Enrollment: 819
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients 18 to 65 years of age, inclusive.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
* Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
* Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

* Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
* Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
* History of meeting DSM-IV-TR criteria for:

  1. Depressive episode with psychotic or catatonic features.
  2. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
  3. Schizophrenia, schizoaffective, or other psychotic disorder.
  4. Obsessive-compulsive disorder.
  5. Bulimia or anorexia nervosa.
  6. Dementia, amnesic, or other cognitive disorder.
  7. Mental retardation.
* Participants considered a suicide risk.

Primary outcomes:
measure: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Forest Investigative Site 077
state: California
city: National City
country: United States
facility: Forest Investigative Site 019
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 039
state: California
city: Orange
country: United States
facility: Forest Investigative Site 015
state: California
city: Orange
country: United States
facility: Forest Investigative Site 050
state: California
city: Redlands
country: United States
facility: Forest Investigative Site 008
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 066
state: California
city: Gainesville
country: United States
facility: Forest Investigative Site 063
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 029
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 023
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 026
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 062
state: Georgia
city: Smyrna
country: United States
facility: Forest Investigative Site 065
state: Georgia
city: Prairie Village
country: United States
facility: Forest Investigative Site 074
state: Kansas
city: Flowood
country: United States
facility: Forest Investigative Site 040
state: Mississippi
city: Creve Coeur
country: United States
facility: Forest Investigative Site 068
state: Missouri
city: Cherry Hill
country: United States
facility: Forest Investigative Site 061
state: New Jersey
city: Marlton
country: United States
facility: Forest Investigative Site 038
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 030
state: New Mexico
city: Brooklyn
country: United States
facility: Forest Investigative Site 076
state: New York
city: Mount Kisco
country: United States
facility: Forest Investigative Site 037
state: New York
city: New York
country: United States
facility: Forest Investigative Site 067
state: New York
city: New York
country: United States
facility: Forest Investigative Site 049
state: New York
city: Canton
country: United States
facility: Forest Investigative Site 047
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 021
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site 022
state: Oregon
city: Salem
country: United States
facility: Forest Investigative Site 027
state: Oregon
city: Bridgeville
country: United States
facility: Forest Investigative Site 069
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 025
state: Pennsylvania
city: Reading
country: United States
facility: Forest Investigative Site 031
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site 048
state: Tennessee
city: Austin
country: United States
facility: Forest Investigative Site 024
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 020
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 070
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 080
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site 028
state: Utah
city: Bellevue
country: United States
facility: Forest Investigative Site 032
state: Washington
city: Kirkland
country: United States
facility: Forest Investigative Site 034
state: Washington
city: Tallinn
country: Estonia
facility: Forest Investigative Site 203
city: Tallinn
country: Estonia
facility: Forest Investigative Site 201
city: Tallinn
country: Estonia
facility: Forest Investigative Site 206
city: Tallinn
country: Estonia
facility: Forest Investigative Site 205
city: Tartu
country: Estonia
facility: Forest Investigative Site 204
city: Tartu
country: Estonia
facility: Forest Investigative Site 208
city: Tartu
country: Estonia
facility: Forest Investigative Site 207
city: Võru
country: Estonia
facility: Forest Investigative Site 202
city: Helsinki
country: Finland
facility: Forest Investigative Site 301
city: Helsinki
country: Finland
facility: Forest Investigative Site 302
city: Helsinki
country: Finland
facility: Forest Investigative Site 304
city: Helsinki
country: Finland
facility: Forest Investigative Site 303
city: Kuopio
country: Finland
facility: Forest Investigative Site 305
city: Oulu
country: Finland
facility: Forest Investigative Site 308
city: Pori
country: Finland
facility: Forest Investigative Site 307
city: Banska Stiavnica
country: Slovakia
facility: Forest Investigative Site 602
city: Bardejov
country: Slovakia
facility: Forest Investigative Site 603
city: Bratislava
country: Slovakia
facility: Forest Investigative Site 604
city: Bratislava
country: Slovakia
facility: Forest Investigative Site 606
city: Michalovce
country: Slovakia
facility: Forest Investigative Site 601
city: Rimavska Sobota
country: Slovakia
facility: Forest Investigative Site 605
city: Rimavska Sobota
country: Slovakia
facility: Forest Investigative Site 607
city: Lund
country: Sweden
facility: Forest Investigative Site 803
city: Malmö
country: Sweden
facility: Forest Investigative Site 802
city: Stockholm
country: Sweden
facility: Forest Investigative Site 801
city: Stepanivka
country: Ukraine
facility: Forest Investigative Site 705
state: Kherson
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 703
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 704
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 702
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 701
city: Lugansk
country: Ukraine
facility: Forest Investigative Site 710
city: Odesa
country: Ukraine
facility: Forest Investigative Site 709
city: Vinnytsia
country: Ukraine
facility: Forest Investigative Site 706
Study officials:
affiliation: Allergan
name: Willie Earley, MD
role: STUDY_DIRECTOR
References:
citation: Durgam S, Earley W, Guo H, Li D, Nemeth G, Laszlovszky I, Fava M, Montgomery SA. Efficacy and safety of adjunctive cariprazine in inadequate responders to antidepressants: a randomized, double-blind, placebo-controlled study in adult patients with major depressive disorder. J Clin Psychiatry. 2016 Mar;77(3):371-8. doi: 10.4088/JCP.15m10070.