Bipolar DepressionPhase 2NCT00852202

Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

A Phase 2 study testing cariprazine in people with Bipolar Depression, run by Forest Laboratories at 26 sites in United States.

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 purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Depression
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: 234 participants
Where: 26 sitesUnited States
Study dates: 30 Jun 2009to 15 Jun 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 Bipolar I or II Disorder without psychotic features, with a current depressive episode
A verified previous manic, hypomanic, or mixed episode
Score of 20 or higher on the HAMD-17
Score of 2 or higher on Item 1 of the HAMD

Who cannot join

Score greater than 12 on the Young Mania Rating Scale
Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Forest Investigative Site 009
Bellevue, Washington, 98004
Forest Investigative Site 020
Bradenton, Florida, 34208
Forest Investigative Site 028
Cherry Hill, New Jersey, 08002
Forest Investigative Site 029
Creve Coeur, Missouri, 63141
Forest Investigative Site 004
Dayton, Ohio, 45417
Forest Investigative Site 018
Durham, North Carolina, 27710
Forest Investigative Site 005
Encino, California, 91316
Forest Investigative Site 017
Garden Grove, California, 92845
Forest Investigative Site 024
Glen Burnie, Maryland, 21061
Forest Investigative Site 023
Irving, Texas, 75062
Forest Investigative Site 007
Jacksonville, Florida, 32216
Forest Investigative Site 019
Kissimmee, Florida, 34741
Forest Investigative Site 022
Mason, Ohio, 45040
Forest Investigative Site 006
Media, Pennsylvania, 19063
Forest Investigative Site 014
Nashville, Tennessee, 37212
Forest Investigative Site 027
National City, California, 91950
Forest Investigative Site 013
Newport Beach, California, 92660
Forest Investigative Site 010
Oceanside, California, 92056
Forest Investigative Site 002
Omaha, Nebraska, 68131
Forest Investigative Site 026
Orlando, Florida, 32806
Forest Investigative Site 011
Philadelphia, Pennsylvania, 19107
Forest Investigative Site 015
Portland, Oregon, 97210
Forest Investigative Site 016
Seattle, Washington, 98104
Forest Investigative Site 001
The Bronx, New York, 10467
Forest Investigative Site 012
West Palm Beach, Florida, 33407
Forest Investigative Site 003
Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Conditions: Bipolar Depression
Being tested: cariprazine, placebo
Keywords: bipolar, depression
Medical subject headings: Bipolar Disorder, Depression

What participants receive

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

cariprazineDrug
Drug: cariprazine (0.25 - 0.75 mg/day)
cariprazineDrug
Drug: cariprazine (1.5 - 3.0 mg/day)
placeboDrug
placebo capsules, oral administration, once daily dosing

Study groups in NCT00852202
Study group	Role	What they receive
1	Experimental	0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. Receives: Drug: cariprazine
2	Experimental	1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing. Receives: Drug: cariprazine
3	Placebo comparator	Matching placebo capsules, oral administration, once daily dosing. Receives: Drug: placebo

What is being measured

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

Change From Baseline in 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.
Measured: Baseline to Week 8

Secondary outcomes (1)

Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )
The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.
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.

30 Jun 200915 Jun 2010

First posted26 Feb 2009 (estimated)
Study start30 Jun 2009
Primary completion15 Jun 2010
Study completion15 Jun 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 Bipolar DepressionStudies 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: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00852202
Sponsor's protocol ID: RGH-MD-52
Status last verified: Aug 2018
First submitted: 25 Feb 2009
Last updated: 23 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.
PubMed 31969269

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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Safety and Feasibility of DBS for Bipolar Depression
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All Bipolar Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression
ClinicalTrials.gov ID: NCT00852202
Acronym / sponsor ID: RGH-MD-52
Conditions: Bipolar Depression
Keywords: bipolar, depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Gedeon Richter Ltd.
Study start: 30 Jun 2009 (actual)
Primary completion: 15 Jun 2010 (actual)
Study completion: 15 Jun 2010 (actual)
First posted: 26 Feb 2009 (estimated)
Results: Posted 23 Aug 2018

Clinical summary

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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: cariprazine0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
2	Experimental	Drug: cariprazine1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
3	Placebo comparator	Drug: placeboMatching placebo capsules, oral administration, once daily dosing.

Who may qualify

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

Key inclusion criteria (5 listed)

Men and women, 18-65 years old
Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
A verified previous manic, hypomanic, or mixed episode
Score of 20 or higher on the HAMD-17
Score of 2 or higher on Item 1 of the HAMD

Key exclusion criteria (3 listed)

Score greater than 12 on the Young Mania Rating Scale
Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)

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
cariprazineDrug: cariprazine (0.25 - 0.75 mg/day)	Drug	1
cariprazineDrug: cariprazine (1.5 - 3.0 mg/day)	Drug	2
placeboplacebo capsules, oral administration, once daily dosing	Drug	3

Primary outcome

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline to Week 8
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.

1 secondary outcome

Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )
Time frame: Baseline to Week 8

Results and safety

Results posted to the registry on 23 Aug 2018, 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	77	60
0.25 to 0.75 mg Cariprazine	75	63
1.5 to 3.0 mg Cariprazine	75	49

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

Time frame: Baseline to Week 8. Mean (Standard Error). Unit: Score on scale

Measure	Placebo n = 60	0.25 to 0.75 mg Cariprazine n = 64	1.5 to 3.0 mg Cariprazine n = 54
Value	29.9 (0.6)	30.2 (0.6)	30.9 (0.6)

Placebo vs 0.25 to 0.75 mg Cariprazine: p = 0.7408, ANCOVA
Placebo vs 1.5 to 3.0 mg Cariprazine: p = 0.9961, ANCOVA

Population analysed: of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 54 for 1.5 to 3.0 mg Cariprazine

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 77 (2.6%)	51 of 77 (66.2%)	Not reported
0.25 to 0.75 mg Cariprazine	2 of 75 (2.7%)	48 of 75 (64%)	Not reported
1.5 to 3.0 mg Cariprazine	2 of 75 (2.7%)	52 of 75 (69.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31969269Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.

Related trials for Bipolar Depression

Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
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RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
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Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
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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.

William Greenberg, MD study director

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

26 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 cariprazine in people with Bipolar Depression, run by Forest Laboratories at 26 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 5 inclusion and 3 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 23 Aug 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 Montgomery-Asberg Depression Rating Scale (MADRS) (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 NCT00852202, 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 23 Aug 2018.