Major Depressive DisorderPhase 2NCT00854100
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
A Phase 2 study testing Antidepressant + cariprazine (0.1-0.3 mg/day) and Antidepressant + cariprazine (1-2 mg/d) in people with Major Depressive Disorder, run by Forest Laboratories at 41 sites in United States.
Trial summary
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy. 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?
- Antidepressant + cariprazine (0.1-0.3 mg/day) and Antidepressant + cariprazine (1-2 mg/d)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 41 sitesUnited States
- Study dates
- 30 Jun 2009to 6 Dec 2010
- 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
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
- Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.
Who cannot join
- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Forest Investigative Site
Arcadia, California, 91007
Forest Investigative Site 033
Atlanta, Georgia, 30306
Forest Investigative Site
Bellevue, Washington, 98007
Forest Investigative Site 043
Brooklyn, New York, 11235
Forest Investigative Site
Canton, Ohio, 44718
Forest Investigative Site
Cherry Hill, New Jersey, 08002
Forest Investigative Site
Dayton, Ohio, 45417
Forest Investigative Site 025
Denver, Colorado, 80239
Forest Investigative Site
Encino, California, 91316
Forest Investigative Site 042
Fall River, Massachusetts, 02721
Forest Investigative Site
Garden Grove, California, 92845
Forest Investigative Site
Irvine, California, 92618
Forest Investigative Site 007
Jacksonville, Florida, 32216
Forest Investigative Site 013
Los Alamitos, California, 90720
Forest Investigative Site 006
Media, Pennsylvania, 19063
Forest Investigative Site 023
Memphis, Tennessee, 38119
Forest Investigative Site 031
Memphis, Tennessee, 38119
Forest Investigative Site 020
Mount Kisco, New York, 10549
Forest Investigative Site
Nashville, Tennessee, 37212
Forest Investigative Site 041
National City, California, 91950
Forest Investigative Site 039
New York, New York, 10003
Forest Investigative Site 029
New York, New York, 10021
Forest Investigative Site
Norwich, Connecticut, 06360
Forest Investigative Site
Oceanside, California, 92056
Forest Investigative Site
Omaha, Nebraska, 68131
Forest Investigative Site
Overland Park, Kansas, 66211
Forest Investigative Site
Philadelphia, Pennsylvania, 19104
Forest Investigative Site
Philadelphia, Pennsylvania, 19107
Forest Investigative Site 040
Phoenix, Arizona, 85050
Forest Investigative Site 034
Pittsfield, Massachusetts, 01267
Forest Investigative Site 015
Portland, Oregon, 97210
Forest Investigative Site 032
Raleigh, North Carolina, 27607
Forest Investigative Site
Richmond, Virginia, 23230
Forest Investigative Site
Roswell, Georgia, 30076
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site 038
Scottsdale, Arizona, 85254
Forest Investigative Site
Seattle, Washington, 98104
Forest Investigative Site 001
The Bronx, New York, 10467
Forest Investigative Site
Washington D.C., District of Columbia, 20016
Forest Investigative Site 012
West Palm Beach, Florida, 33407
Forest Investigative Site
Woodstock, Vermont, 05091
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
- Conditions
- Major Depressive Disorder
- Being tested
- Antidepressant + placebo, Antidepressant + cariprazine (0.1-0.3 mg/day), Antidepressant + cariprazine (1-2 mg/d)
- Keywords
- Adjunctive, Depression, Major Depressive Disorder (MDD)
- 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.
Antidepressant + placeboDrug
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
Antidepressant + cariprazine (0.1-0.3 mg/day)Drug
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
Antidepressant + cariprazine (1-2 mg/d)Drug
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Receives: Drug: Antidepressant + placebo |
| Cariprazine 0.1 - 0.3 mg | Experimental | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose Receives: Drug: Antidepressant + cariprazine (0.1-0.3 mg/day) |
| Cariprazine 1.0 - 2.0 mg | Experimental | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose Receives: Drug: Antidepressant + cariprazine (1-2 mg/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
Measured: Baseline (Week 8) to Week 16
Secondary outcomes (1)
Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study start30 Jun 2009
- Primary completion6 Dec 2010
- Study completion6 Dec 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Responsible party
- Sponsor
- Investigators
- Robert Hayes, PhD, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854100
- Sponsor's protocol ID
- RGH-MD-71
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2009
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235.
PubMed 30045066
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00854100
- Acronym / sponsor ID
- RGH-MD-71
- Conditions
- Major Depressive Disorder
- Keywords
- Adjunctive, Depression, Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 6 Dec 2010 (actual)
- Study completion
- 6 Dec 2010 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
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: Antidepressant + placeboDrug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo |
| Cariprazine 0.1 - 0.3 mg | Experimental | Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose |
| Cariprazine 1.0 - 2.0 mg | Experimental | Drug: Antidepressant + cariprazine (1-2 mg/d)Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
- Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.
Key exclusion criteria (1 listed)
- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
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 |
|---|---|---|
| Antidepressant + placeboDrug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. | Drug | Placebo |
| Antidepressant + cariprazine (0.1-0.3 mg/day)Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. | Drug | Cariprazine 0.1 - 0.3 mg |
| Antidepressant + cariprazine (1-2 mg/d)Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. | Drug | Cariprazine 1.0 - 2.0 mg |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline (Week 8) to Week 16
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
1 secondary outcome
Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30045066Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235.
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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.
Robert Hayes, PhD study director
Forest Laboratories
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antidepressant + cariprazine (0.1-0.3 mg/day) and Antidepressant + cariprazine (1-2 mg/d) in people with Major Depressive Disorder, run by Forest Laboratories at 41 sites 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 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites 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?
Yes. Results are posted in the registry (first posted 5 Mar 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) (time frame: Baseline (Week 8) to Week 16). 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 NCT00854100, 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 5 Mar 2019.