CompletedNCT01567527Updated Aug 24, 2018Results posted

Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients

A Phase 3 interventional study of Intramuscular (IM) Depot Aripiprazole and Intramuscular (IM) Depot Placebo in Bipolar I Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 77 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 731
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder, according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI), who have experienced at least one previous manic episode of sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic agent in addition to their current manic episode. All subjects must be experiencing a manic episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients and outpatients are eligible for this trial.

This trial will consist of a screening phase followed by 4 treatment phases. Subjects will undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM depot stabilization phase, and, a double-blind, placebo-controlled phase.

Conditions studied

Bipolar I Disorder

Keywords

Aripiprazole
Intramuscular (IM) Depot
Bipolar

In context

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
Subjects with a current diagnosis of bipolar I disorder, as defined by DSM-IV-TR criteria and confirmed by the MINI and a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent, in addition to their current manic episode. "Require" is defined as an intervention that occurred rather than one that was recommended. Rapid cyclers with 8 or fewer episodes in the previous year will be included.
Subjects currently experiencing a manic episode with a YMRS total score of ≥20 at the Screening Visit.
Subjects can have an inpatient or outpatient status prior to entry into Phase C (IM depot stabilization).
In the investigator's opinion, subjects who are able to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole IM depot injection, and discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete subject-reported outcomes measures; and who can be reliably rated on assessment scales.

Key Exclusion Criteria:

Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar I disorder.
Subjects who have NOT experienced at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer, and /or treatment with an antipsychotic agent, excluding their current manic episode. "Require" is defined as a intervention that occurred rather than one that was recommended.
Subjects with bipolar I disorder who are considered resistant/refractory to treatment for manic symptoms by history.
Subjects unresponsive to clozapine for treatment of mania.
Subjects with a significant risk of committing suicide based on history, mental status examination, investigator's judgment, or C-SSRS answer of "yes" to question 4 or 5 (current or within the last 90 days).
Subjects with a current manic episode with a duration of > 2 years.
Subjects who currently (within the past month) meet DSM-IV-TR criteria for substance abuse or substance dependence; this includes the abuse of alcohol and benzodiazepines, but excludes the use of caffeine and/or nicotine.
Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator.
Subjects who are currently experiencing a mixed or a depressive episode (per DSM-IV-TR criteria).
Subjects with a history of hypersensitivity to antipsychotic agents.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 731 participants (actual)

Study arms

Active comparator
1
Active Comparator: Treatment of Aripiprazole IM Depot
Drug: Intramuscular (IM) Depot Aripiprazole
Placebo comparator
2
Placebo Comparator: Treatment of IM Depot Placebo
Drug: Intramuscular (IM) Depot Placebo

Interventions

DrugIntramuscular (IM) Depot Aripiprazole
Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection
DrugIntramuscular (IM) Depot Placebo
Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection

What researchers measure

Primary outcomes

Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.
This endpoint was defined as meeting any of the following criteria: 1. Hospitalization for any mood episode OR 2. Any of the following: 1. YMRS total score ≥ 15 OR 2. MADRS total score ≥ 15 OR 3. CGI-BP-S score \> 4 (overall score) OR 3. SAE of worsening disease (bipolar I disorder) OR 4. Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR 5. Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, or increase greater than the allowed benzodiazepine doses, or 6. Active suicidality, which is defined as a score of 4 or more on the MADRS item 10 OR an answer of "yes" on question 4 or 5 on the C-SSRS. The time to event is presented in the following table.
Time frame: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).

Secondary outcomes

Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.
To assess the proportion of subjects who met criteria for recurrence of any mood episode (manic, mixed or depressive). Hierarchical procedure was used to preserve the overall Type I error at 0.05.
Time frame: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).
Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.
CGI-BP-S assessed the subject's severity of Illness (mania) based on a 7-point scale ranging from 1 (normal/ not ill at all) to 7 (very severely ill).
Time frame: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).
Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.
Analysis of time from randomization to recurrence defined by hospitalization for a mood episode (Double-blind, Placebo-controlled Phase efficacy sample). Time to recurrence is presented in the following table.
Time frame: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).

Results

Posted Aug 24, 2018

Participant flow

This trial was conducted in 1175 subjects (including 444 screen failures) at 103 trial sites in the following 7 countries: Canada, Japan, Republic of Korea, Poland, Romania, Taiwan, and the United States (US).

Conversion Phase.

Participant flow — Conversion Phase.
Milestone	Conversion Phase.	Oral Aripiprazole Stabilization Phase.	Intramuscular (IM) Depot Stabilization Phase.	Double-blind Placebo-controlled Phase - Aripiprazole IM Depot.	Double-blind Placebo-controlled Phase - Placebo.
Started	466	0	0	0	0
Completed	367	0	0	0	0
Not completed	99	0	0	0	0
Withdrew: Protocol deviation	3	0	0	0	0
Withdrew: Met withdrawal criteria	10	0	0	0	0
Withdrew: Withdrawal by subject	32	0	0	0	0
Withdrew: Lost to follow-up	16	0	0	0	0
Withdrew: Lack of efficacy	2	0	0	0	0
Withdrew: Adverse event	33	0	0	0	0
Withdrew: Withdrawn by the investigator	3	0	0	0	0

Oral Aripiprazole Stabilization Phase.

Participant flow — Oral Aripiprazole Stabilization Phase.
Milestone	Conversion Phase.	Oral Aripiprazole Stabilization Phase.	Intramuscular (IM) Depot Stabilization Phase.	Double-blind Placebo-controlled Phase - Aripiprazole IM Depot.	Double-blind Placebo-controlled Phase - Placebo.
Started	0	632	0	0	0
Completed	0	425	0	0	0
Not completed	0	207	0	0	0
Withdrew: Met withdrawal criteria	0	41	0	0	0
Withdrew: Withdrawal by subject	0	45	0	0	0
Withdrew: Lost to follow-up	0	44	0	0	0
Withdrew: Lack of efficacy	0	12	0	0	0
Withdrew: Adverse event	0	63	0	0	0
Withdrew: Withdrawn by the investigator	0	2	0	0	0

IM Depot Stabilization.

Participant flow — IM Depot Stabilization.
Milestone	Conversion Phase.	Oral Aripiprazole Stabilization Phase.	Intramuscular (IM) Depot Stabilization Phase.	Double-blind Placebo-controlled Phase - Aripiprazole IM Depot.	Double-blind Placebo-controlled Phase - Placebo.
Started	0	0	425	0	0
Completed	0	0	266	0	0
Not completed	0	0	159	0	0
Withdrew: Protocol deviation	0	0	5	0	0
Withdrew: Met withdrawal criteria	0	0	26	0	0
Withdrew: Withdrawal by subject	0	0	56	0	0
Withdrew: Sponsor discontinued study	0	0	1	0	0
Withdrew: Lost to follow-up	0	0	21	0	0
Withdrew: Lack of efficacy	0	0	7	0	0
Withdrew: Adverse event	0	0	37	0	0
Withdrew: Withdrawn by the investigator	0	0	6	0	0

Double-blind, Placebo-controlled Phase

Participant flow — Double-blind, Placebo-controlled Phase
Milestone	Double-blind Placebo-controlled Phase - Aripiprazole IM Depot.	Double-blind Placebo-controlled Phase - Placebo.
Started	133	133
Completed	64	38
Not completed	69	95
Withdrew: Protocol deviation	1	1
Withdrew: Recurrence of any mood episode with ae	16	33
Withdrew: Met withdrawal criteria	4	7
Withdrew: Ae without recurrence of any moodepisode	7	1
Withdrew: Withdrawal by subject	13	10
Withdrew: Sponsor discontinued study	1	3
Withdrew: Recurrence of any mood episode withoutae	19	35
Withdrew: Lost to follow-up	8	5

Outcome measures

PrimaryTime From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.

This endpoint was defined as meeting any of the following criteria: 1. Hospitalization for any mood episode OR 2. Any of the following: 1. YMRS total score ≥ 15 OR 2. MADRS total score ≥ 15 OR 3. CGI-BP-S score \> 4 (overall score) OR 3. SAE of worsening disease (bipolar I disorder) OR 4. Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR 5. Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, or increase greater than the allowed benzodiazepine doses, or 6. Active suicidality, which is defined as a score of 4 or more on the MADRS item 10 OR an answer of "yes" on question 4 or 5 on the C-SSRS. The time to event is presented in the following table.

Time frame:: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).
Reported as:: Median · Days

Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.
Days	Aripiprazole IM Depot	Placebo
Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.	NA (NA to NA)	308 (178 to NA)

Statistical analysis

Aripiprazole IM Depot vs Placebo · Log Rank · p = < 0.0001 · Hazard ratio (hr): 0.451 · 95% CI 0.299 to 0.678Using the Cox proportional hazards model with term for treatment group. HR is estimated for Aripiprazole IM depot relative to Placebo.
Aripiprazole IM Depot vs Placebo · Hazard ratio (hr): 2.22 · 95% CI 1.475 to 3.34HR is estimated for Placebo relative to Aripiprazole IM depot.

SecondaryNumber of Subjects Meeting Criteria for Recurrence of Any Mood Episode.

To assess the proportion of subjects who met criteria for recurrence of any mood episode (manic, mixed or depressive). Hierarchical procedure was used to preserve the overall Type I error at 0.05.

Time frame:: Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).
Reported as:: Count of participants · Participants

Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.
Participants	Aripiprazole IM Depot	Placebo
Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.	35	68

Statistical analysis

Aripiprazole IM Depot vs Placebo · Fisher Exact · p = < 0.0001 · Percentage difference (final values): -24.6 · 95% CI -36.7 to -12.5

SecondaryMean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.

CGI-BP-S assessed the subject's severity of Illness (mania) based on a 7-point scale ranging from 1 (normal/ not ill at all) to 7 (very severely ill).

Time frame:: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).
Reported as:: Least squares mean · Units on a scale

Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.
Units on a scale	Aripiprazole IM Depot	Placebo
Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.	-0.16 ± 0.058	0.27 ± 0.126

Statistical analysis

Aripiprazole IM Depot vs Placebo · Mixed model repeated measure analysis · p = = 0.0011 · Mean difference (final values): -0.43 · 95% CI -0.69 to -0.17

SecondaryTime From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.

Analysis of time from randomization to recurrence defined by hospitalization for a mood episode (Double-blind, Placebo-controlled Phase efficacy sample). Time to recurrence is presented in the following table.

Time frame:: Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).
Reported as:: Median · Days

Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.
Days	Aripiprazole IM Depot	Placebo
Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Aripiprazole IM Depot vs Placebo · Log Rank · p = = 0.0002 · Hazard ratio (hr): 0.137 · 95% CI 0.04 to 0.465Using the Cox proportional hazards model with term for treatment group. HR is estimated for Aripiprazole IM depot relative to Placebo.
Aripiprazole IM Depot vs Placebo · Hazard ratio (hr): 7.313 · 95% CI 2.151 to 24.865HR is estimated for Placebo relative to Aripiprazole IM depot.

Adverse events

Collected over Any AEs were recorded from the signing of informed consent up to 52 weeks (end of the study).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Conversion Phase.	0/459 (0%)	32/459 (7%)	180/459 (39.2%)
Oral Aripiprazole Stabilization Phase.	1/614 (0.2%)	35/614 (5.7%)	196/614 (31.9%)
IM Depot Stabilization Phase.	0/425 (0%)	36/425 (8.5%)	194/425 (45.6%)
Aripiprazole IM Depot- Double-blind, Placebo-controlled Phase.	1/132 (0.8%)	10/132 (7.6%)	66/132 (50%)
Placebo-Double-blind, Placebo-controlled Phase.	0/133 (0%)	25/133 (18.8%)	62/133 (46.6%)

Most frequent serious events

Showing 10 of 49

Most frequent serious events
Event	Conversion Phase.	Oral Aripiprazole Stabilization Phase.	IM Depot Stabilization Phase.	Aripiprazole IM Depot- Double-blind, Placebo-controlled Phase.	Placebo-Double-blind, Placebo-controlled Phase.
ManiaPsychiatric disorders	13/459	17/614	7/425	2/132	10/133
Bipolar disorderPsychiatric disorders	6/459	2/614	0/425	1/132	3/133
Bipolar I disorderPsychiatric disorders	4/459	1/614	4/425	2/132	3/133
DepressionPsychiatric disorders	0/459	4/614	8/425	0/132	0/133
Major depressionPsychiatric disorders	1/459	1/614	0/425	0/132	2/133
Atrial FibrillationCardiac disorders	0/459	0/614	1/425	1/132	0/133
Cardio-respiratory arrestCardiac disorders	0/459	0/614	0/425	1/132	0/133
AsthmaRespiratory, thoracic and mediastinal disorders	1/459	0/614	1/425	1/132	0/133
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/459	0/614	0/425	1/132	0/133
AkathisiaNervous system disorders	3/459	1/614	0/425	1/132	0/133

Most frequent other events

Most frequent other events
Event	Conversion Phase.	Oral Aripiprazole Stabilization Phase.	IM Depot Stabilization Phase.	Aripiprazole IM Depot- Double-blind, Placebo-controlled Phase.	Placebo-Double-blind, Placebo-controlled Phase.
Weight increasedInvestigations	13/459	22/614	47/425	31/132	24/133
AkathisiaNervous system disorders	76/459	94/614	74/425	27/132	17/133
NasopharyngitisInfections and infestations	18/459	11/614	22/425	10/132	13/133
InsomniaPsychiatric disorders	35/459	34/614	41/425	10/132	10/133
RestlessnessPsychiatric disorders	36/459	32/614	24/425	6/132	5/133
AnxietyPsychiatric disorders	19/459	24/614	30/425	9/132	6/133
HeadacheNervous system disorders	31/459	13/614	12/425	4/132	9/133
FatigueGeneral disorders	14/459	19/614	22/425	4/132	5/133

Baseline characteristics

Baseline characteristics were presented for the subjects randomized to Double-blind Placebo-controlled Phase. The Double-blind, Placebo-controlled Phase Efficacy Sample consisted of all randomized subjects who received at least 1 injection of IMP and had at least 1 post-baseline efficacy assessment.

Age, Categorical
Age, Categorical(Participants)	Aripiprazole Depot	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	133	132	265
>=65 years	0	1	1

Age, Continuous
Age, Continuous(years)	Aripiprazole Depot	Placebo	Total
Mean	40.6 ± 10.8	40.6 ± 11.2	40.6 ± 11.0

Sex: Female, Male
Sex: Female, Male(Participants)	Aripiprazole Depot	Placebo	Total
Female	83	70	153
Male	50	63	113

Region of Enrollment
Region of Enrollment(Participants)	Aripiprazole Depot	Placebo	Total
Canada	2	0	2
South Korea	7	7	14
Romania	8	12	20
United States	101	102	203
Japan	9	10	19
Taiwan	2	1	3
Poland	4	1	5

Age at first manic episode (years)
Age at first manic episode (years)(years)	Aripiprazole Depot	Placebo	Total
Mean	25.2 ± 10.3	24.8 ± 9.9	25.0 ± 10.1

Number of mood episodes past 12 months
Number of mood episodes past 12 months(Mood episodes)	Aripiprazole Depot	Placebo	Total
Mean	2.2 ± 1.2	2.2 ± 1.1	2.2 ± 1.2

Duration of disease prior to enrollment (years)
Duration of disease prior to enrollment (years)(years)	Aripiprazole Depot	Placebo	Total
Mean	12.1 ± 9.2	13.6 ± 9.8	12.9 ± 9.5

Number of prior hospitalizations for a mood episode
Number of prior hospitalizations for a mood episode(Prior hospitalization for mood episode)	Aripiprazole Depot	Placebo	Total
Mean	3.5 ± 3.9	3.5 ± 4.1	3.5 ± 4.0

3 further baseline measures are reported on the registry.

Study locations

77 sites

Birmingham, Alabama, United States
Springdale, Arkansas, United States
Beverly Hills, California, United States
Costa Mesa, California, United States
Escondido, California, United States
Garden Grove, California, United States
Los Angeles, California, United States
National City, California, United States
Oceanside, California, United States
Orange, California, United States
Pico Rivera, California, United States
Riverside, California, United States
San Diego, California, United States
Temecula, California, United States
Torrance, California, United States
Lauderhill, Florida, United States
Leesburg, Florida, United States
Melbourne, Florida, United States
Oakland Park, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Smyrna, Georgia, United States
Hoffman Estates, Illinois, United States
New Orleans, Louisiana, United States
Rockville, Maryland, United States
Flowood, Mississippi, United States
Saint Charles, Missouri, United States
Saint Louis, Missouri, United States
Lincoln, Nebraska, United States
Cherry Hill, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Wichita Falls, Texas, United States
Richmond, Virginia, United States
Chatham, Ontario, Canada
Aizu Wakamatsu, Fukusima, Japan
Sapporo, Hokkaido, Japan
Morioka, Iwate, Japan
Kawasaki-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kashihara, Nara, Japan
Sakai-shi, Osaka, Japan
Sakai, Osaka, Japan
Fukuoka, Japan
Itabashi-bu, Japan
Kanzaki-gun, Japan
Koriyama-shi, Japan
Kumamoto, Japan
Okinawa, Japan
Shinjuku-ku, Japan
Tokyo, Japan
Tottori, Japan
Toyama, Japan
Anyang-si, Gyeonggi-do, Korea, Republic of
Goyang-si, Gyeonggi-do, Korea, Republic of
Daejeon, Korea, Republic of
Jeju-si, Korea, Republic of
Seoul, Korea, Republic of
Gdynia, Pomorskie, Poland
Bydgoszcz, Poland
Chelmno, Poland
Choroszcz, Poland
Targoviste, Dyambovita, Romania
Bucharest, Romania
Judet Lasi, Romania
Keelung City, Taiwan
Taipei, Taiwan
Taouyuan County, Taiwan

References and documents

Publications

Calabrese JR, Sanchez R, Jin N, Amatniek J, Cox K, Johnson B, Perry P, Hertel P, Such P, Salzman PM, McQuade RD, Nyilas M, Carson WH. Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled, 52-Week Randomized Withdrawal Study. J Clin Psychiatry. 2017 Mar;78(3):324-331. doi: 10.4088/JCP.16m11201. PubMed 28146613 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01567527
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: H. Lundbeck A/S
Responsible party: Sponsor
First posted: Mar 30, 2012
Start date: Aug 2012
Primary completion: Apr 2016
Completion: Apr 2016
Results posted: Aug 24, 2018
Last update: Aug 24, 2018

Study contacts

Stacy Wu, MD

study director · Otsuka Pharmaceutical Development and Commercialization, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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