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Major Depressive DisorderPhase 2NCT01469377

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

A Phase 2 study testing Cariprazine in people with Major Depressive Disorder, run by Forest Laboratories at 72 sites in 6 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

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. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
819 participants
Where
72 sitesin 6 countries
Study dates
15 Dec 2011to 12 Dec 2013
Phase
Phase 2
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

  • 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).

Who cannot join

  • 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:
  • Depressive episode with psychotic or catatonic features.
  • Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
  • Schizophrenia, schizoaffective, or other psychotic disorder.
Show all 11Show fewer
  • Obsessive-compulsive disorder.
  • Bulimia or anorexia nervosa.
  • Dementia, amnesic, or other cognitive disorder.
  • Mental retardation.
  • Participants considered a suicide risk.

Trial locations and contacts

72 sites in 6 countries.

72 sites in 6 countries

United States39 sites

  • Forest Investigative Site 030

    Albuquerque, New Mexico, 87106

  • Forest Investigative Site 062

    Atlanta, Georgia, 30328

  • Forest Investigative Site 024

    Austin, Texas, 78731

  • Forest Investigative Site 032

    Bellevue, Washington, 98007

  • Forest Investigative Site 069

    Bridgeville, Pennsylvania, 15017

  • Forest Investigative Site 076

    Brooklyn, New York, 11235

  • Forest Investigative Site 047

    Canton, Ohio, 44718

  • Forest Investigative Site 061

    Cherry Hill, New Jersey, 08002

  • Forest Investigative Site 068

    Creve Coeur, Missouri, 63141

  • Forest Investigative Site 020

    Dallas, Texas, 75231

  • Forest Investigative Site 021

    Dayton, Ohio, 45417

  • Forest Investigative Site 040

    Flowood, Mississippi, 39232

  • Forest Investigative Site 063

    Gainesville, Florida, 32607

  • Forest Investigative Site 077

    Garden Grove, California, 92845

  • Forest Investigative Site 070

    Houston, Texas, 77054

  • Forest Investigative Site 029

    Jacksonville, Florida, 32256

  • Forest Investigative Site 034

    Kirkland, Washington, 98033

  • Forest Investigative Site 012

    Kissimmee, Florida, 34741

  • Forest Investigative Site 038

    Marlton, New Jersey, 08053

  • Forest Investigative Site 048

    Memphis, Tennessee, 38119

  • Forest Investigative Site 023

    Miami, Florida, 33183

  • Forest Investigative Site 037

    Mount Kisco, New York, 10549

  • Forest Investigative Site 019

    National City, California, 91950

  • Forest Investigative Site 067

    New York, New York, 10021

  • Forest Investigative Site 049

    New York, New York, 10168

  • Forest Investigative Site 039

    Oceanside, California, 92056

  • Forest Investigative Site 015

    Orange, California, 92868

  • Forest Investigative Site 050

    Orange, California, 92868

  • Forest Investigative Site 026

    Orlando, Florida, 32806

  • Forest Investigative Site 025

    Philadelphia, Pennsylvania, 19139

  • Forest Investigative Site 022

    Portland, Oregon, 97210

  • Forest Investigative Site 074

    Prairie Village, Kansas, 66206

  • Forest Investigative Site 031

    Reading, Pennsylvania, 19604

  • Forest Investigative Site 008

    Redlands, California, 92374

  • Forest Investigative Site 027

    Salem, Oregon, 97301

  • Forest Investigative Site 028

    Salt Lake City, Utah, 84106

  • Forest Investigative Site 080

    San Antonio, Texas, 78229

  • Forest Investigative Site 066

    Sherman Oaks, California, 91403

  • Forest Investigative Site 065

    Smyrna, Georgia, 30080

Other trials in United States

Estonia8 sites

  • Forest Investigative Site 203

    Tallinn, 10614

  • Forest Investigative Site 201

    Tallinn, 10617

  • Forest Investigative Site 206

    Tallinn, 11615

  • Forest Investigative Site 205

    Tallinn, 13517

  • Forest Investigative Site 204

    Tartu, 50406

  • Forest Investigative Site 208

    Tartu, 50417

  • Forest Investigative Site 207

    Tartu, 51014

  • Forest Investigative Site 202

    Võru, 65608

Other trials in Estonia

Ukraine8 sites

  • Forest Investigative Site 703

    Kharkiv, 61068

  • Forest Investigative Site 704

    Kharkiv, 61068

  • Forest Investigative Site 702

    Kyiv, 02660

  • Forest Investigative Site 701

    Kyiv, 04080

  • Forest Investigative Site 710

    Luhansk, 91045

  • Forest Investigative Site 709

    Odesa, 65014

  • Forest Investigative Site 705

    Stepanivka, Kherson Oblast, 73488

  • Forest Investigative Site 706

    Vinnytsia, 21005

Other trials in Ukraine

Finland7 sites

  • Forest Investigative Site 301

    Helsinki, 100

  • Forest Investigative Site 302

    Helsinki, 100

  • Forest Investigative Site 304

    Helsinki, 100

  • Forest Investigative Site 303

    Helsinki, 40100

  • Forest Investigative Site 305

    Kuopio, 70110

  • Forest Investigative Site 308

    Oulu, 90100

  • Forest Investigative Site 307

    Pori, 28100

Other trials in Finland

Slovakia7 sites

  • Forest Investigative Site 602

    Banská Štiavnica, 96901

  • Forest Investigative Site 603

    Bardejov, 08501

  • Forest Investigative Site 604

    Bratislava, 82007

  • Forest Investigative Site 606

    Bratislava, 85101

  • Forest Investigative Site 601

    Michalovce, 7101

  • Forest Investigative Site 605

    Rimavská Sobota, 97901

  • Forest Investigative Site 607

    Rimavská Sobota, 97912

Other trials in Slovakia

Sweden3 sites

  • Forest Investigative Site 803

    Lund, 22222

  • Forest Investigative Site 802

    Malmö, 21152

  • Forest Investigative Site 801

    Stockholm, 17145

Other trials in Sweden

About this study

Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder

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.

Being tested
Placebo, Cariprazine
Keywords
Major depressive disorder, Depression
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo was supplied in capsules

  • CariprazineDrug

    Cariprazine was supplied in capsules.

Study groups in NCT01469377
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Receives: Drug: Placebo
Cariprazine 1-2 mgExperimentalParticipants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Receives: Drug: Cariprazine
Cariprazine 2-4.5 mgExperimentalParticipants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator's discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Receives: Drug: Cariprazine

What is being measured

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

  1. Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8

    The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

    Measured: Baseline to Week 8

Secondary outcomes (1)

  1. Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8

    The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.

    Measured: Baseline to Week 8

Timeline

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

  1. First posted10 Nov 2011 (estimated)
  2. Study start15 Dec 2011
  3. Primary completion12 Dec 2013
  4. Study completion12 Dec 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
819 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01469377
Sponsor's protocol ID
RGH-MD-75
Status last verified
Mar 2018
First submitted
8 Nov 2011
Last updated
1 May 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 27046309

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cariprazine in people with Major Depressive Disorder, run by Forest Laboratories at 72 sites in 6 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 4 inclusion and 11 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Estonia, Ukraine, Finland, Slovakia and 1 more country. 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?

Yes. Results are posted in the registry (first posted 1 May 2018). 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?

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 (time frame: Baseline to Week 8). 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 NCT01469377, 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 1 May 2018.

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