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A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03573297
Collaborator
(none)
822
Enrollment
112
Locations
3
Arms
50.8
Anticipated Duration (Months)
7.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/d compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/d
Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
822 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Actual Study Start Date :
Jun 18, 2018
Anticipated Primary Completion Date :
Sep 8, 2022
Anticipated Study Completion Date :
Sep 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cariprazine 3 mg/day

Cariprazine capsules, oral administration, once daily

Drug: Cariprazine
Cariprazine capsules, oral administration, once daily
Experimental: Cariprazine 1.5 mg/day

Cariprazine capsules, oral administration, once daily

Drug: Cariprazine
Cariprazine capsules, oral administration, once daily
Placebo Comparator: Placebo

Matching placebo capsules, oral administration, once daily

Drug: Placebo
Matching placebo capsules, oral administration, once daily

Outcome Measures

Primary Outcome Measures

  1. Number of days to first relapse of any mood episode during the double-blind treatment period [From Visit 10 (Week 12) to Visit 31(Week 55)]

    Relapse will be defined as the occurrence of any 1 of the following: Young Mania Rating Score (YMRS) total score ≥ 17 Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20; Clinical Global Impression-Improvement scale (CGI-S) ≥ 4; Initiation of additional psychiatric medication; Psychiatric hospitalization; Exacerbation of illness as judged by clinical impression of the Investigator

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, current episode manic, with or without mixed features;

  • A total YMRS score ≥ 20 and a score of at least 4 on 2 of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior, or bipolar I disorder, current episode depressive, with or without mixed features;

  • Having a MADRS total score ≥ 23 and a score of at least 3 on 2 of the following MADRS items: apparent sadness, reported sadness, inner tension or inability to feel.

Exclusion Criteria:

  • Four or more episodes of a mood disturbance within the 12 months before Visit 1;

  • Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Woodland International Research Group /ID# 232932 Little Rock Arkansas United States 72211
2 Woodland Research Northwest, LLC /ID# 232982 Rogers Arkansas United States 72758-6442
3 California Pharmaceutical Research Institute Inc. /ID# 232745 Anaheim California United States 92804
4 Advanced Research Center /ID# 233120 Anaheim California United States 92805
5 CI Trials /ID# 232642 Bellflower California United States 90706-7079
6 Synexus Clinical Research US Inc. /ID# 232743 Cerritos California United States 90703
7 ATP Clinical Research, Inc /ID# 232979 Costa Mesa California United States 92626-4607
8 ProScience Research Group /ID# 232945 Culver City California United States 90230-6632
9 Collaborative Neuroscience Research - Orange County /ID# 233077 Garden Grove California United States 92845
10 Behavioral Research Specialists, LLC /ID# 232980 Glendale California United States 91206-4261
11 Omega Clinical Trials LLC /ID# 233150 La Habra California United States 90631-3842
12 Synergy San Diego /ID# 232740 Lemon Grove California United States 91945-2956
13 Alliance for Research - Long Beach /ID# 232926 Long Beach California United States 90807
14 Orange County Neuropsychiatric Research Center LLC /ID# 232741 Orange California United States 92868
15 CNRI-San Diego /ID# 232748 San Diego California United States 92102
16 Artemis Institute for Clinical Research /ID# 233151 San Marcos California United States 92078-2338
17 Artemis Institute for Clinical Research /ID# 233152 San Marcos California United States 92078-2338
18 Collaborative Neuroscience Research LLC /ID# 232750 Torrance California United States 90502
19 Duplicate_MCB Clinical Research Centers LLC /ID# 232838 Colorado Springs Colorado United States 80910
20 Research Centers of America - Hollywood FL /ID# 232649 Hollywood Florida United States 33024-2706
21 CNS Healthcare - Jacksonville /ID# 233160 Jacksonville Florida United States 32256-6039
22 Accel Research Sites-Maitland Clinical Research Unit /ID# 232941 Maitland Florida United States 32751
23 Miami Lakes Medical Research /ID# 232826 Miami Lakes Florida United States 33016
24 University of South Florida /ID# 233093 Tampa Florida United States 33612
25 Synexus Clinical Research, Inc /ID# 232950 Atlanta Georgia United States 30328
26 Atlanta Center for Medical Research /ID# 232832 Atlanta Georgia United States 30331
27 iResearch Atlanta, LLC /ID# 233045 Decatur Georgia United States 30030
28 Atlanta Behavioral Research, LLC /ID# 232935 Dunwoody Georgia United States 30338
29 NeuroPsychiatric Research Practice & Associate LTD /ID# 232840 Winfield Illinois United States 60190
30 Louisiana Clinical Research /ID# 232685 Shreveport Louisiana United States 71101
31 CBH Health LLC /ID# 232699 Gaithersburg Maryland United States 20877
32 St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709 Saint Charles Missouri United States 63304
33 Duplicate_Altea Research Institute /ID# 232784 Las Vegas Nevada United States 89102
34 Hassman Research Institute /ID# 233088 Berlin New Jersey United States 08009
35 Neurobehavioral Research Inc /ID# 232791 Cedarhurst New York United States 11516
36 New Hope Clinical Research Inc. /ID# 232716 Charlotte North Carolina United States 28211
37 Richard Weisler MD, PA & Assoc /ID# 233049 Raleigh North Carolina United States 27609
38 Clinical Inquest Center Ltd /ID# 233043 Beavercreek Ohio United States 45431-2573
39 DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739 Columbus Ohio United States 43210
40 Midwest Clinical Research Center /ID# 232737 Dayton Ohio United States 45417
41 Sooner Clinical Research /ID# 232931 Oklahoma City Oklahoma United States 73112
42 Velocity Clinical Research - Medford /ID# 232647 Medford Oregon United States 97504
43 Community Clinical Research Inc. /ID# 232672 Austin Texas United States 78754
44 Pillar Clinical Research LLC /ID# 232667 Richardson Texas United States 75080
45 Pillar Healthcare /ID# 232673 Richardson Texas United States 75080
46 Family Psychiatry of The Woodlands /ID# 232943 The Woodlands Texas United States 77381
47 Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777 Burgas Bulgaria 8001
48 State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779 Kardzhali Bulgaria 6600
49 MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893 Kazanlak Bulgaria 6100
50 State Psychiatric Hospital - Lovech /ID# 232771 Lovech Bulgaria 5500
51 Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773 Pleven Bulgaria 5800
52 UMHAT Dr Georgi Stranski EAD /ID# 233105 Pleven Bulgaria 5800
53 UMHAT Kanev /ID# 233101 Ruse Bulgaria 7002
54 Clinic of Child Psychiatry St Nicolas /ID# 232925 Sofia Bulgaria 1431
55 MHAT Targovishte /ID# 232942 Targovishte Bulgaria 7700
56 Inje University Busan Paik Hospital /ID# 233097 Busan Korea, Republic of 47392
57 Inje University Haeundae Hospital /ID# 233141 Busan Korea, Republic of 48108
58 Chonnam National University Hospital /ID# 233098 Gwangju Korea, Republic of 61469
59 Jeju National University Hospital /ID# 233104 Jeju Korea, Republic of 63238
60 Duplicate_Chonbuk National University Hospital /ID# 232654 Jeonju Korea, Republic of 54907
61 Hospital Raja Permaisuri Bainun /ID# 233114 Ipoh Perak Malaysia 30450
62 University Malaya Med Ctr /ID# 233108 Kuala Lumpur Malaysia 59100
63 Specjalistyczny Gabinet Lekarski /ID# 232702 Lublin Lubelskie Poland 20-582
64 Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848 Gdansk Pomorskie Poland 80-546
65 Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170 Poznan Slaskie Poland 60-744
66 Poradnia Zdrowia Psychicznego /ID# 232878 Chelmno Poland 86-200
67 INSPIRA Clinical Research /ID# 232704 San Juan Puerto Rico 00918
68 Spitalul Universitar de Urgenta Militar Central Dr Carol Davila /ID# 232903 Bucharest Bucuresti Romania 010825
69 Spitalul de Psihiatrie TITAN /ID# 232904 Bucuresti Romania 030442
70 CETTT SF Stelian Hospital /ID# 232882 Bucuresti Romania 060222
71 Spitalul Clinic Judeatean Mures /ID# 232857 Targu Mures Romania 540142
72 Kazan State Medical University /ID# 233110 Kazan Tatarstan, Respublika Russian Federation 420012
73 Mental Health Research Centre /ID# 232864 Moscow Russian Federation 115522
74 Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946 Nizhny Novgorod Russian Federation 603155
75 Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933 Orenburg Russian Federation 460006
76 State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872 Roschino Russian Federation 188820
77 I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930 Saint Petersburg Russian Federation 197341
78 St. Nicolas Psychiatric Hospital /ID# 232858 Saint-Petersburg Russian Federation 190121
79 St. Nicolas Psychiatric Hospital /ID# 232859 Saint-Petersburg Russian Federation 190121
80 Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936 Saratov Russian Federation 410028
81 Regional Clinical Psychiatry Hospital /ID# 232856 Saratov Russian Federation 410060
82 National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927 St. Petersburg Russian Federation 192019
83 National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928 St. Petersburg Russian Federation 192019
84 Ltd Clinic Hundred Years /ID# 232866 Tomsk Russian Federation 634009
85 Region Specialized Psychiatric Hospital #2 /ID# 232850 Tonnelniy Russian Federation 357034
86 University Clinical Center Serbia /ID# 233095 Belgrade Beograd Serbia 11000
87 University Clinical Center Kragujevac /ID# 233096 Kragujevac Sumadijski Okrug Serbia 34000
88 Clinical Center Vojvodina /ID# 233038 Novi Sad Vojvodina Serbia 21000
89 Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641 Belgrade Serbia 11040
90 Institute of Mental Health /ID# 232958 Belgrade Serbia 11108
91 Special Hospital for Psychiatric Diseases Kovin /ID# 232829 Kovin Serbia 26220
92 Clinical Centre Kragujevac /ID# 232874 Kragujevac Serbia 34000
93 Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846 Novi Knezevac Serbia 23330
94 Taipei Veterans General Hospital /ID# 232947 Taipei City Taipei Taiwan 11217
95 Taipei Tzu Chi Hospital /ID# 233128 New Taipei Taiwan 23142
96 China Medical University Hospital /ID# 233091 Taichung City Taiwan 40447
97 National Cheng Kung University Hospital /ID# 233109 Tainan Taiwan 704
98 Tri-Service General Hospital /ID# 233078 Taipei City Taiwan 11490
99 Maharaj Nakorn Chiang Mai Hospital /ID# 232860 Chiang Mai Thailand 50200
100 Suan Prung Psychiatric Hospital /ID# 232862 Muang Thailand 50100
101 Cherkasy regional psychiatric hospital of the CRC /ID# 232686 Smila Cherkaska Oblast Ukraine 20708
102 Geikivka multidisciplinary hospital for psychiatric care /ID# 232678 Kryvbas Village Dnipropetrovska Oblast Ukraine 53054
103 SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937 Kharkiv Kharkivska Oblast Ukraine 61068
104 SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938 Kharkiv Kharkivska Oblast Ukraine 61068
105 SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939 Kharkiv Kharkivska Oblast Ukraine 61068
106 Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684 Stepanivka Village Khersonska Oblast Ukraine 73488
107 Odesa regional psychiatric hospital 2 of the ORC /ID# 232682 Oleksandrivka Village Odeska Oblast Ukraine 67513
108 KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680 Uzhgorod Zakarpatska Oblast Ukraine 88000
109 Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876 Lviv Ukraine 79021
110 MNCE Odesa Regional Medical Center for Mental Health /ID# 232944 Odesa Ukraine 65006
111 CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853 Vinnytsia Ukraine 21005
112 Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852 Vinnytsia Ukraine 21005

Sponsors and Collaborators

  • AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03573297
Other Study ID Numbers:
  • RGH-MD-25
  • 2017-000803-25
First Posted:
Jun 29, 2018
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Disease
Cariprazine

Study Results

No Results Posted as of May 25, 2022