Depression, BipolarPhase 2NCT01396447

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

A Phase 2 study testing Cariprazine in people with Depression, Bipolar, run by Forest Laboratories at 88 sites in 6 countries.

Completed

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

Official record

Search all trials

Trial summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression, Bipolar
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: 584 participants
Where: 88 sitesin 6 countries
Study dates: 26 Jul 2011to 10 Jan 2014
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

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
Participants with a HAMD-17 item 1 score ≥ 2.
Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Who cannot join

Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score > 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Trial locations and contacts

88 sites in 6 countries.

Country

City, postcode or hospital

88 sites in 6 countries

United States38 sites

Forest Investigative Site 006
Albuquerque, New Mexico, 87109
Forest Investigative Site 009
Allentown, Pennsylvania, 18104
Forest Investigative Site 038
Atlanta, Georgia, 30308
Forest Investigative Site 005
Atlanta, Georgia, 30328
Forest Investigative Site 043
Bellevue, Washington, 98007
Forest Investigative Site 030
Beverly Hills, California, 90210
Forest Investigative Site 021
Birmingham, Alabama, 35216
Forest Investigative Site 003
Brooklyn, New York, 11214
Forest Investigative Site 036
Canton, Ohio, 44718
Forest Investigative Site 018
Cerritos, California, 90703
Forest Investigative Site 023
Cherry Hill, New Jersey, 08002
Forest Investigative Site 029
Chicago, Illinois, 60640
Forest Investigative Site 028
Costa Mesa, California, 92626
Forest Investigative Site 026
Creve Coeur, Missouri, 63141
Forest Investigative Site 007
Dallas, Texas, 75231
Forest Investigative Site 008
Dayton, Ohio, 45417
Forest Investigative Site 039
Flowood, Mississippi, 39232
Forest Investigative Site 016
Houston, Texas, 77008
Forest Investigative Site 027
Houston, Texas, 77054
Forest Investigative Site 024
Indianapolis, Indiana, 46260
Forest Investigative Site 012
Jacksonville, Florida, 32256
Forest Investigative Site 041
Lake Charles, Louisiana, 70629
Forest Investigative Site 037
Las Vegas, Nevada, 89102
Forest Investigative Site 033
Lincoln, Rhode Island, 02865
Forest Investigative Site 014
Marlton, New Jersey, 08053
Forest Investigative Site 010
Media, Pennsylvania, 19063
Forest Investigative Site 019
Memphis, Tennessee, 38119
Forest Investigative Site 025
New York, New York, 10021
Forest Investigative Site 015
Oceanside, California, 92056
Forest Investigative Site 035
Orlando, Florida, 32806
Forest Investigative Site 031
Prairie Village, Kansas, 66206
Forest Investigative Site 042
Salem, Oregon, 97301
Forest Investigative Site 020
San Antonio, Texas, 78229
Forest Investigative Site 032
Seattle, Washington, 98104
Forest Investigative Site 040
Shreveport, Louisiana, 71104
Forest Investigative Site 017
Springdale, Arkansas, 72764
Forest Investigative Site 011
Temecula, California, 92591
Forest Investigative Site 013
Winter Park, Florida, 32789

Other trials in United States

Russia18 sites

Forest Investigative Site 601
Arkhangelsk, 163530
Forest Investigative Site 605
Moscow, 107076
Forest Investigative Site 607
Moscow, 115522
Forest Investigative Site 611
Moscow, 117152
Forest Investigative Site 619
Moscow, 127083
Forest Investigative Site 603
Nizhny Novgorod, 603152
Forest Investigative Site 604
Saint Petersburg, 190005
Forest Investigative Site 606
Saint Petersburg, 190121
Forest Investigative Site 602
Saint Petersburg, 191119
Forest Investigative Site 613
Saint Petersburg, 191119
Forest Investigative Site 608
Saint Petersburg, 192019
Forest Investigative Site 615
Saint Petersburg, 192019
Forest Investigative Site 612
Saint Petersburg, 199034
Forest Investigative Site 617
Samara, 443016
Forest Investigative Site 616
Saratov, 410028
Forest Investigative Site 609
Tomsk, 634014
Forest Investigative Site 618
Tver', 170005
Forest Investigative Site 610
Voronezh, 394052

Other trials in Russia

Ukraine12 sites

Forest Investigative Site 714
Donetsk, 83008
Forest Investigative Site 712
Ivano-Frankivsk, 76014
Forest Investigative Site 707
Kerch, AR Crimea, 98310
Forest Investigative Site 703
Kharkiv, 61068
Forest Investigative Site 704
Kharkiv, 61068
Forest Investigative Site 702
Kharkiv, 61103
Forest Investigative Site 709
Kherson, Vil. Stepanivka, 73488
Forest Investigative Site 708
Kyiv, 02660
Forest Investigative Site 701
Kyiv, 04080
Forest Investigative Site 710
Odesa, 65014
Forest Investigative Site 706
Simferopol, 95006
Forest Investigative Site 705
Vinnytsia, 21005

Other trials in Ukraine

Bulgaria11 sites

Forest Investigative Site 311
Kardzhali, 6600
Forest Investigative Site 307
Kazanlak, 6100
Forest Investigative Site 310
Lovech, 5500
Forest Investigative Site 313
Novi Iskar, 1282
Forest Investigative Site 309
Pazardzhik, 4400
Forest Investigative Site 302
Pleven, 5800
Forest Investigative Site 301
Plovdiv, 4002
Forest Investigative Site 305
Sofia, 1431
Forest Investigative Site 306
Sofia, 1431
Forest Investigative Site 308
Tsarev Brod, 9747
Forest Investigative Site 312
Tserova Koria, 5047

Other trials in Bulgaria

Colombia6 sites

Forest Investigative Site 804
Barranquilla
Forest Investigative Site 806
Barranquilla
Forest Investigative Site 803
Bogotá
Forest Investigative Site 805
Bogotá
Forest Investigative Site 808
Bogotá
Forest Investigative Site 807
Pereira

Other trials in Colombia

Canada3 sites

Forest Investigative Site 101
Chatham, Ontario, N7L 5L9
Forest Investigative Site 102
Kelowna, British Columbia, V1Y 1Z9
Forest Investigative Site 103
Penticton, British Columbia, V2A 4M4

Other trials in Canada

About this study

Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Conditions: Depression, Bipolar
Being tested: Placebo, Cariprazine
Keywords: Bipolar I disorder, Bipolar depression, Depression, Bipolar disorder
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.

PlaceboDrug
Placebo was supplied in capsules.
CariprazineDrug
Cariprazine was supplied in capsules.

Study groups in NCT01396447
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo orally once a day for 8 weeks. Receives: Drug: Placebo
Cariprazine 0.75 mg	Experimental	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period. Receives: Drug: Cariprazine
Cariprazine 1.5 mg	Experimental	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period. Receives: Drug: Cariprazine
Cariprazine 3.0 mg	Experimental	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period. Receives: Drug: Cariprazine

What is being measured

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

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.
Measured: Baseline to Week 6

Secondary outcomes (1)

Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Measured: Baseline to Week 6

Timeline

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

26 Jul 201110 Jan 2014

First posted18 Jul 2011 (estimated)
Study start26 Jul 2011
Primary completion10 Jan 2014
Study completion10 Jan 2014

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 (7)Papers the sponsor has linked to this study.
Other trials for Depression, BipolarStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 584 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01396447
Sponsor's protocol ID: RGH-MD-56
Other IDs: 2011-002334-39
Status last verified: Mar 2018
First submitted: 15 Jul 2011
Last updated: 1 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.
PubMed 39520655
Vieta E, Calabrese JR, Whelan J, Tohen M, Earley WR. The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial. Curr Med Res Opin. 2021 Sep;37(9):1635-1643. doi: 10.1080/03007995.2021.1932446. Epub 2021 Jun 7.
PubMed 34034612
Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.
PubMed 33915374
Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.
PubMed 33677183
Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.
PubMed 32942346
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
Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, Nemeth G, Vieta E, Calabrese JR, Yatham LN. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016 Mar 1;173(3):271-81. doi: 10.1176/appi.ajp.2015.15020164. Epub 2015 Nov 6.
PubMed 26541814

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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All Depression, Bipolar trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
ClinicalTrials.gov ID: NCT01396447
Acronym / sponsor ID: RGH-MD-56
Conditions: Depression, Bipolar
Keywords: Bipolar I disorder, Bipolar depression, Depression, Bipolar disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 584 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Gedeon Richter Ltd.
Study start: 26 Jul 2011 (actual)
Primary completion: 10 Jan 2014 (actual)
Study completion: 10 Jan 2014 (actual)
First posted: 18 Jul 2011 (estimated)
Results: Posted 1 May 2018

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 was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Study design

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

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo orally once a day for 8 weeks.
Cariprazine 0.75 mg	Experimental	Drug: CariprazineParticipants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
Cariprazine 1.5 mg	Experimental	Drug: CariprazineParticipants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
Cariprazine 3.0 mg	Experimental	Drug: CariprazineParticipants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.

Who may qualify

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

Key inclusion criteria (7 listed)

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.

Key exclusion criteria (4 listed)

Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score > 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

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
PlaceboPlacebo was supplied in capsules.	Drug	Placebo
CariprazineCariprazine was supplied in capsules.	Drug	Cariprazine 0.75 mg, Cariprazine 1.5 mg, Cariprazine 3.0 mg

Primary outcome

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
Time frame: Baseline to Week 6
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.

1 secondary outcome

Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6
Time frame: Baseline to Week 6

Results and safety

Results posted to the registry on 1 May 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	148	105
Cariprazine 0.75 mg	143	103
Cariprazine 1.5 mg	147	117
Cariprazine 3.0 mg	146	94

Primary outcome: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6

Time frame: Baseline to Week 6. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 141	Cariprazine 0.75 mg n = 140	Cariprazine 1.5 mg n = 145	Cariprazine 3.0 mg n = 145
Value	-11.1 (0.9)	-13.0 (0.9)	-15.1 (0.8)	-13.7 (0.9)

Placebo vs Cariprazine 0.75 mg: Mean Difference (Final Values): -1.9 (95% CI -4.3 to 0.5), p = 0.1292, Repeated measures mixed-effects model
Placebo vs Cariprazine 1.5 mg: Mean Difference (Final Values): -4.0 (95% CI -6.3 to -1.6), p = 0.0010, Repeated measures mixed-effects model
Placebo vs Cariprazine 3.0 mg: Mean Difference (Final Values): -2.5 (95% CI -4.9 to -0.1), p = 0.0374, Repeated measures mixed-effects model

Population analysed: Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 145 (3.4%)	42 of 145 (29%)	0 of 145
Cariprazine 0.75 mg	1 of 141 (0.7%)	43 of 141 (30.5%)	0 of 141
Cariprazine 1.5 mg	2 of 146 (1.4%)	51 of 146 (34.9%)	0 of 146
Cariprazine 3.0 mg	2 of 146 (1.4%)	56 of 146 (38.4%)	0 of 146

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39520655McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.
Derived from this study: PubMed 34034612Vieta E, Calabrese JR, Whelan J, Tohen M, Earley WR. The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial. Curr Med Res Opin. 2021 Sep;37(9):1635-1643. doi: 10.1080/03007995.2021.1932446. Epub 2021 Jun 7.
Derived from this study: PubMed 33915374Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.
Derived from this study: PubMed 33677183Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.
Derived from this study: PubMed 32942346Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.
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.
Derived from this study: PubMed 26541814Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, Nemeth G, Vieta E, Calabrese JR, Yatham LN. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016 Mar 1;173(3):271-81. doi: 10.1176/appi.ajp.2015.15020164. Epub 2015 Nov 6.

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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

88 sites in 6 countries: 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 Depression, Bipolar, run by Forest Laboratories at 88 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 7 inclusion and 4 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 88 sites in United States, Russia, Ukraine, Bulgaria, Colombia 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 Total Score at Week 6 (time frame: Baseline to Week 6). 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 NCT01396447, which also lists 7 linked publications.

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.