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SchizophreniaPhase 1/2NCT04030143

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

A Phase 1/2 study testing Aripiprazole in people with Schizophrenia and Bipolar I Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 19 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 trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Schizophrenia, Bipolar I Disorder
What is being tested?
Aripiprazole
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
19 sitesUnited States
Study dates
1 Aug 2019to 8 Jul 2020
Phase
Phase 1/2
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
  • Body mass index of 18 to 35 kilograms per meter square (kg/m^2).
  • On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.

Who cannot join

  • Participants who have:
  • Met DSM-5 criteria for substance use disorder within the past 180 days.
  • A positive drug screen for drugs of abuse
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
Show all 14Show fewer
  • Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
  • Participants currently in an acute relapse of schizophrenia.
  • Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
  • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
  • Participants deemed intolerant of receiving injections.
  • Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Atlanta Center for Medical Research - Atlanta

    Atlanta, Georgia, 30331

  • Community Clinical Research

    Austin, Texas, 78754

  • CITrials - Bellflower

    Bellflower, California, 90706

  • Carolina Clinical Trials

    Charleston, South Carolina, 29407

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • CBH Health

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Network

    Garden Grove, California, 92845

  • California Clinical Trials Medical Group

    Glendale, California, 91206

  • Research Centers of America

    Hollywood, Florida, 33024

  • Altea Research Institute - Las Vegas

    Las Vegas, Nevada, 89102

  • Synergy Research Centers

    Lemon Grove, California, 91945

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Hassman Research Institute

    Marlton, New Jersey, 08009

  • Segal Institute For Clinical Research - West Broward Outpatient Clinic

    Miami Lakes, Florida, 33016

  • NRC Research Institute

    Orange, California, 92868

  • Woodland International Research Group

    Rogers, Arkansas, 72758

  • California Neuropsychopharmacology Clinical Research Institute San Diego

    San Diego, California, 92102

  • St. Louis Clinical Trials

    St Louis, Missouri, 63141

  • Collaborative Neuroscience Network - South Bay

    Torrance, California, 90502

Other trials in United States

About this study

Official title: A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

Being tested
Aripiprazole
Keywords
Aripiprazole, Aripiprazole Intramuscular Depot, Gluteal Muscle, Long Acting Injection
Medical subject headings
Schizophrenia

What participants receive

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

  • AripiprazoleDrug

    Also called OPC-14597, Lu AF41155

    Administered as an intramuscular (IM) depot injection.

  • AripiprazoleDrug

    Also called OPC-14597, Lu AF41155

    Administered as an IM depot injection.

Study groups in NCT04030143
Study groupRoleWhat they receive
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I DisorderExperimentalParticipants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
Receives: Drug: Aripiprazole
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I DisorderExperimentalParticipants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Receives: Drug: Aripiprazole

What is being measured

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

  1. Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP.

    Measured: From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)

  2. Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities

    Potentially clinically significant vital sign abnormalities included: heart rate supine (high: >120 beats per minute [BPM] and increase >=15 BPM; low: <50 BPM and decrease >=15 BPM), systolic blood pressure supine (high >180 (millimetres of mercury [mmHg] and increase >=20 mmHg); low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure supine (high: >105 mmHg and increase >=15 mmHg; low: <50 mmHg and decrease >=15 mmHg), heart rate standing (high: >120 BPM and increase >=15 BPM), systolic blood pressure standing (high: >180 mmHg and increase >= 20 mmHg; low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure standing (high: >105 mmHg and increase >=15 mmHg), weight in kilograms (kg) (high: increase >=7%; low: decrease >=7%), temperature (high: >=37.8 degree celsius [°C] and increase >=1.1°C), orthostatic hypotension (low: >=20 mmHg decrease in systolic blood pressure and >=25 BPM increase in heart rate from supine to standing.

    Measured: From first dose of study drug up to Day 225

  3. Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities

    Potentially clinically significant ECG abnormalities included rate: bradycardia (vent <=50 BPM] and decrease >=15 BPM); rhythm: sinus bradycardia (<= 50 BPM and decrease >= 15 BPM and no current diagnosis of atrial fibrillation, atrial flutter, or other rhythm abnormality); supraventricular premature beat (not present at baseline and present post baseline); ventricular premature beat (not present at baseline and present post baseline); conduction: right bundle branch block (not present at baseline and present post baseline); ST/T morphology: myocardial ischemia and symmetrical T-wave inversion (not present at baseline and present post baseline), QTcB, QTcF, and QTcN (>=450 milliseconds [msec] and >= 10% increase).

    Measured: From first dose of study drug up to Day 225

  4. Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities

    Potentially clinically relevant laboratory abnormalities included: In units per liter [U/L] (alanine aminotransferase: male[M]/female[F] >=3 x upper limit of normal (ULN); aspartate aminotransferase: M/F >= 3 x ULN; creatine kinase: M/F >= 3 x ULN); in milligrams per deciliter (mg/dL) (creatinine: M/F >= 2.0; glucose: M/F >= 200; urate: M >=10.5, F >=8.5); potassium [milliequivalents per liter (mEq/L)]: M/F >=5.5, in percentage (%) (eosinophils/leukocytes: M/F>=10%, hematocrit: M<=37%/F<=32% and 3 point decrease from baseline); hemoglobin (grams per deciliter [g/dL]): M<=11.5/F<=9.5; leukocytes [10^9 per liter (/L)]: M/F<=2.8 x 10^3 per microliters (/uL); platelets (10^9/L): M/F>=700 x 10^3/uL; glucose, urine and protein, urine: increase of >=2 units; and prolactin (nanograms per milliliter [ng/mL]: M/F > 1 x ULN.

    Measured: From first dose of study drug up to Day 225

  5. Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score

    The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms.

    Measured: Baseline, Week 32

  6. Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score

    The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). AIMS movement score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms.

    Measured: Baseline, Week 32

  7. Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score

    The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. Total BARS score ranges from 0 to 14 where lower scores indicate less symptoms and negative change from baseline indicate less symptoms.

    Measured: Baseline, Week 32

  8. Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg

    Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful).

    Measured: Day 1 (First injection) to Day 169 (Last injection)

  9. VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg

    Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful).

    Measured: Day 1 (First injection) to Day 197 (Last injection)

  10. Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection

    Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant.

    Measured: Day 1 (First injection) to Day 169 (Last injection)

  11. Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection

    Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant.

    Measured: Day 1 (First injection) to Day 197 (Last injection)

  12. Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior. Suicidality was defined as reporting any suicidal ideation or behavior.

    Measured: Baseline to Day 225

  13. Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose

    Measured: Day 225

  14. Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose

    Measured: Day 225

  15. Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg

    Measured: Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197 (predose and 4, 8, 12 hours post dose), 198, 199, 201, 204, 206, 209, 211, 214, 218, 225

  16. Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg

    Measured: Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

Secondary outcomes (21)

  1. Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

    Measured: Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

  2. Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

    Measured: Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

  3. AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg

    Measured: Days 1 (predose and 4, 8, 12 hours post-dose), 2, 3, 5, 8, 10, 13, 15, 18, 22, 29, 36, 43, 50 and 57 (pre-dose)

  4. Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg

    Measured: Predose on Day 57

  5. AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg

    Measured: Days 169 (predose and 4, 8, 12 hours postdose), 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197

  6. Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

    Measured: Days 204, 211, 218, and 225

  7. Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

    PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following fourth dose.

    Measured: Days 169 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

  8. Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

    Measured: Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225

  9. Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

    Measured: Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225

  10. AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg

    Measured: Days 1 (predose and 4, 8, and 12 hours postdose), 2, 3, 5, 8, 10, 13, 15, 18, 22 and 29 (predose)

  11. Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg

    Measured: Predose on Day 29

  12. PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg

    PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following eighth dose.

    Measured: Days 197 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose),198, 199, 201, 204, 206, 209, 211, 214, 218, 225

  13. Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg

    Measured: Day 8

  14. Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg

    Measured: Day 15

  15. Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score

    The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worse condition. The PANSS was assessed for schizophrenia participants only.

    Measured: Baseline, Week 32

  16. Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score

    The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The cumulative score range is 0-7. A higher score on the CGI-S represents a higher severity of disease. The CGI-S scale was assessed for schizophrenia participants only.

    Measured: Baseline, Week 32

  17. Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score

    The CGI-I scale is a clinician rated scale which assesses the improvement of illness for each participant. To assess CGI-I, the rater or investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared with the participant's condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Scores range from 0 to 7. Higher scores indicate worse condition.

    Measured: Baseline, Week 32

  18. Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score

    The participant's feeling of their own well-being was assessed using the 20-question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of well-being while receiving antipsychotic medication. The questionnaire consisted of 20 items (10 positive and 10 negative statements) and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', the response choices and scoring is not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, and very much = 6. For items marked with a '- ', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 1 (none) to 6 (severe), and total score ranged from 20 to 120, with higher scores indicating stronger subjective feeling

    Measured: Baseline, Week 32

  19. Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    The MADRS is a diagnostic questionnaire used by clinician to assess the participant's severity of depression. This scale consists of 10 items each with 7 defined grades of severity on 0 to 6 scale (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). MADRS total score is sum of 10 individual item scores ranging from 0-60 categorized as: 0 to 6: normal/symptoms absent, 7 to 19: mild depression, 20 to 34: moderate depression, and 35 to 60: severe depression. Higher score indicates more depressive symptoms. The MADRS was assessed for bipolar I disorder participants only.

    Measured: Baseline, Week 32

  20. Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

    The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score range is from 0 to 60 and the higher score represent a worse outcome. The YMRS was assessed for bipolar I disorder participants only.

    Measured: Baseline, Week 32

  21. Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score

    The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale ranging from 1 (normal, not ill) to 7 (very severely ill). A negative change score signifies improvement. The CGI-BP was assessed for bipolar I disorder participants only.

    Measured: Baseline, Week 32

Timeline

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

  1. First posted23 Jul 2019
  2. Study start1 Aug 2019
  3. Primary completion8 Jul 2020
  4. Study completion8 Jul 2020

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04030143
Sponsor's protocol ID
031-201-00181
Status last verified
Oct 2023
First submitted
19 Jul 2019
Last updated
18 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Publications

  • Citrome L, Such P, Yildirim M, Madera-McDonough J, Beckham C, Zhang Z, Larsen F, Harlin M. Safety and Efficacy of Aripiprazole 2-Month Ready-to-Use 960 mg: Secondary Analysis of Outcomes in Adult Patients With Schizophrenia in a Randomized, Open-label, Parallel-Arm, Pivotal Study. J Clin Psychiatry. 2023 Sep 4;84(5):23m14873. doi: 10.4088/JCP.23m14873.

    PubMed 37672016

  • McIntyre RS, Such P, Yildirim M, Madera-McDonough J, Zhang Z, Larsen F, Harlin M. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study. Curr Med Res Opin. 2023 Jul;39(7):1021-1030. doi: 10.1080/03007995.2023.2219155. Epub 2023 Jun 9.

    PubMed 37272079

  • Harlin M, Yildirim M, Such P, Madera-McDonough J, Jan M, Jin N, Watkin S, Larsen F. A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder. CNS Drugs. 2023 Apr;37(4):337-350. doi: 10.1007/s40263-023-00996-8. Epub 2023 Mar 24.

    PubMed 36961650

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Aripiprazole in people with Schizophrenia and Bipolar I Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 19 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 14 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Nov 2023). 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?

Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)). The study lists 16 primary outcomes in all. 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 NCT04030143, which also lists 3 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 18 Nov 2023.

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