Major Depressive DisorderPhase 3NCT01715805

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

A Phase 3 study testing Cariprazine and Antidepressant Therapy (ADT) in people with Major Depressive Disorder, run by Forest Laboratories at 85 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD 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?: Cariprazine and Antidepressant Therapy (ADT)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,022 participants
Where: 85 sitesin 2 countries
Study dates: 15 Nov 2012to 24 Jun 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients who have provided consent prior to any specific procedure
Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Who cannot join

Patients who do not meet DSM-IV-TR criteria for MDD

Trial locations and contacts

85 sites in 2 countries.

Country

City, postcode or hospital

85 sites in 2 countries

United States83 sites

Forest Investigative Site 058
Albuquerque, New Mexico, 87109
Forest Investigative Site 052
Allentown, Pennsylvania, 18104
Forest Investigative Site 060
Atlanta, Georgia, 30306
Forest Investigative Site 024
Atlanta, Georgia, 30331
Forest Investigative Site 079
Austin, Texas, 78732
Forest Investigative Site 081
Bellevue, Washington, 98007
Forest Investigative Site 067
Bismarck, North Dakota, 58501
Forest Investigative Site 046
Boston, Massachusetts, 02131
Forest Investigative Site 028
Brooklyn, New York, 11214
Forest Investigative Site 088
Canton, Ohio, 44718
Forest Investigative Site 084
Cerritos, California, 90703
Forest Investigative Site 001
Charleston, South Carolina, 29425
Forest Investigative Site 041
Charlottesville, Virginia, 22903
Forest Investigative Site 070
Chicago, Illinois, 60612
Forest Investigative Site 089
Cincinnati, Ohio, 45215
Forest Investigative Site 011
Cincinnati, Ohio, 45219
Forest Investigative Site 015
Cincinnati, Ohio, 45227
Forest Investigative Site 055
Columbus, Ohio, 43210
Forest Investigative Site 037
Coral Springs, Florida, 33067
Forest Investigative Site 085
Culver City, California, 90230
Forest Investigative Site 048
Denver, Colorado, 80239
Forest Investigative Site 050
Durham, North Carolina, 27710
Forest Investigative Site 053
Fort Myers, Florida, 33912
Forest Investigative Site 049
Gaithersburg, Maryland, 20877
Forest Investigative Site 082
Garden Grove, California, 92845
Forest Investigative Site 023
Hallandale, Florida, 33009
Forest Investigative Site 071
Hialeah, Florida, 33012
Forest Investigative Site 013
Hoffman Estates, Illinois, 60169
Forest Investigative Site 005
Houston, Texas, 77008
Forest Investigative Site 061
Indianapolis, Indiana, 46260
Forest Investigative Site 042
Lafayette, Indiana, 47905
Forest Investigative Site 006
Leesburg, Florida, 34748
Forest Investigative Site 063
Libertyville, Illinois, 60048
Forest Investigative Site 059
Lincoln, Rhode Island, 02865
Forest Investigative Site 018
Little Rock, Arkansas, 72211
Forest Investigative Site 029
Little Rock, Arkansas, 72211
Forest Investigative Site 017
Marietta, Georgia, 30060
Forest Investigative Site 066
Mason, Ohio, 45040
Forest Investigative Site 062
Maywood, Illinois, 60153
Forest Investigative Site 026
Miami, Florida, 33145
Forest Investigative Site 075
Miami, Florida, 33165
Forest Investigative Site 064
Middleburg Heights, Ohio, 44130
Forest Investigative Site 056
Milwaukee, Wisconsin, 53227
Forest Investigative Site 072
Naperville, Illinois, 60563
Forest Investigative Site 045
Natick, Massachusetts, 01760
Forest Investigative Site 073
New Orleans, Louisiana, 70115
Forest Investigative Site 016
New York, New York, 10023
Forest Investigative Site 083
New York, New York, 10028
Forest Investigative Site 022
Newport Beach, California, 92660
Forest Investigative Site 027
North Miami, Florida, 33161
Forest Investigative Site 074
North Miami, Florida, 33161
Forest Investigative Site 010
Oak Brook, Illinois, 60523
Forest Investigative Site 036
Oakland Park, Florida, 33334
Forest Investigative Site 004
Oceanside, California, 92056
Forest Investigative Site 035
Oklahoma City, Oklahoma, 73103
Forest Investigative Site 038
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 039
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 030
Orem, Utah, 84058
Forest Investigative Site 051
Orlando, Florida, 32803
Forest Investigative Site 065
Overland Park, Kansas, 66211
Forest Investigative Site 003
Portland, Oregon, 97210
Forest Investigative Site 090
Rancho Mirage, California, 92270
Forest Investigative Site 078
Redlands, California, 92374
Forest Investigative Site 080
Redlands, California, 92374
Forest Investigative Site 077
Rockville, Maryland, 20850
Forest Investigative Site 012
Rockville, Maryland, 20852
Forest Investigative Site 086
Saint Charles, Missouri, 63304
Forest Investigative Site 007
San Diego, California, 92103
Forest Investigative Site 054
San Diego, California, 92108
Forest Investigative Site 043
Seattle, Washington, 98104
Forest Investigative Site 068
Skokie, Illinois, 60076
Forest Investigative Site 047
Smyrna, Georgia, 30080-6315
Forest Investigative Site 044
South Miami, Florida, 33143
Forest Investigative Site 025
Staten Island, New York, 10305
Forest Investigative Site 008
Tampa, Florida, 33613
Forest Investigative Site 031
Temecula, California, 92591
Forest Investigative Site 076
The Bronx, New York, 10467
Forest Investigative Site 087
The Woodlands, Texas, 77381
Forest Investigative Site 014
Toms River, New Jersey, 08755
Forest Investigative Site 032
Tucson, Arizona, 85710
Forest Investigative Site 057
Waukesha, Wisconsin, 53188
Forest Investigative Site 069
Wichita Falls, Texas, 76309
Forest Investigative Site 019
Winter Park, Florida, 32789

Other trials in United States

Puerto Rico2 sites

Forest Investigative Site 033
San Juan, 00918
Forest Investigative Site 034
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Conditions: Major Depressive Disorder
Being tested: Cariprazine, Placebo, Antidepressant Therapy (ADT)
Keywords: MDD, Major Depressive Disorder
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.

CariprazineDrug
Cariprazine capsules 1.5 to 4.5 mg/day
PlaceboDrug
Dose-matched placebo capsule once per day
Antidepressant Therapy (ADT)Drug
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Study groups in NCT01715805
Study group	Role	What they receive
Placebo + ADT Lead-in	Other	Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks. Receives: Drug: Placebo; Drug: Antidepressant Therapy (ADT)
Placebo + ADT (Double-Blind)	Placebo comparator	Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16). Receives: Drug: Placebo; Drug: Antidepressant Therapy (ADT)
Cariprazine + ADT (Double-Blind)	Experimental	Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16). Receives: Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)
Placebo + ADT (Continued Treatment)	Other	Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks. Receives: Drug: Placebo; Drug: Antidepressant Therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.
Measured: Baseline (Week 8)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
Measured: Baseline (Week 8) to Week 16

Secondary outcomes (1)

Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period
The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
Measured: Baseline (Week 8) to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201224 Jun 2016

First posted29 Oct 2012 (estimated)
Study start15 Nov 2012
Primary completion24 Jun 2016
Study completion24 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,022 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01715805
Sponsor's protocol ID: RGH-MD-72
Status last verified: Aug 2019
First submitted: 25 Oct 2012
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
ClinicalTrials.gov ID: NCT01715805
Acronym / sponsor ID: RGH-MD-72
Conditions: Major Depressive Disorder
Keywords: MDD, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,022 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Gedeon Richter Ltd.
Study start: 15 Nov 2012 (actual)
Primary completion: 24 Jun 2016 (actual)
Study completion: 24 Jun 2016 (actual)
First posted: 29 Oct 2012 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo + ADT Lead-in	Other	Drug: Placebo, Drug: Antidepressant Therapy (ADT)Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
Placebo + ADT (Double-Blind)	Placebo comparator	Drug: Placebo, Drug: Antidepressant Therapy (ADT)Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
Cariprazine + ADT (Double-Blind)	Experimental	Drug: Cariprazine, Drug: Antidepressant Therapy (ADT)Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
Placebo + ADT (Continued Treatment)	Other	Drug: Placebo, Drug: Antidepressant Therapy (ADT)Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients who have provided consent prior to any specific procedure
Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Key exclusion criteria (1 listed)

Patients who do not meet DSM-IV-TR criteria for MDD

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
CariprazineCariprazine capsules 1.5 to 4.5 mg/day	Drug	Cariprazine + ADT (Double-Blind)
PlaceboDose-matched placebo capsule once per day	Drug	Placebo + ADT (Continued Treatment), Placebo + ADT (Double-Blind), Placebo + ADT Lead-in
Antidepressant Therapy (ADT)ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.	Drug	Cariprazine + ADT (Double-Blind), Placebo + ADT (Continued Treatment), Placebo + ADT (Double-Blind), Placebo + ADT Lead-in

Primary outcome

Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
Time frame: Baseline (Week 8)
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period
Time frame: Baseline (Week 8) to Week 16
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.

1 secondary outcome

Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period
Time frame: Baseline (Week 8) to Week 16

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo + ADT Lead-in	1,022	807
Placebo + ADT (Double-Blind)	0	0
Cariprazine + ADT (Double-Blind)	0	0
Placebo + ADT (Continued Treatment)	0	0

Primary outcome: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period

Time frame: Baseline (Week 8). Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo + ADT (Double-Blind) n = 258	Cariprazine + ADT (Double-Blind) n = 267
Value	25.2 (6.1)	25.4 (5.5)

Population analysed: Double-blind Intent-to-Treat (ITT) Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.

Primary outcome: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period

Time frame: Baseline (Week 8) to Week 16. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo + ADT (Double-Blind) n = 258	Cariprazine + ADT (Double-Blind) n = 267
Value	-7.5 (0.5)	-7.7 (0.5)

Placebo + ADT (Double-Blind) vs Cariprazine + ADT (Double-Blind): Least Squares Mean Difference (LSMD): -0.2 (95% CI -1.6 to 1.2), p = 0.7948, Mixed Models Analysis

Population analysed: Double-blind ITT Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose of study drug up to 30 days past last dose of study drug (Up to 12 Weeks for the ADT Lead-In arm) and up to an additional 12 weeks for the Double-Blind and Continued Treatment arms. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + ADT Lead-in	9 of 1,022 (0.9%)	261 of 1,022 (25.5%)	0 of 1,022
Placebo + ADT (Double-Blind)	3 of 258 (1.2%)	50 of 258 (19.4%)	0 of 258
Cariprazine + ADT (Double-Blind)	1 of 269 (0.4%)	101 of 269 (37.5%)	0 of 269
Placebo + ADT (Continued Treatment)	1 of 270 (0.4%)	14 of 270 (5.2%)	0 of 270

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Willie Earley, MD study director

Allergan

85 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine and Antidepressant Therapy (ADT) in people with Major Depressive Disorder, run by Forest Laboratories at 85 sites in 2 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 3 inclusion and 1 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period (time frame: Baseline (Week 8)). The study lists 2 primary outcomes in all. 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 NCT01715805.

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 28 Aug 2019.