Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia.

The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole depot; Drug: Placebo depot

Detailed Description

This was a randomized, double-blind, placebo-controlled study consisting of a screening phase and 4 treatment phases. Eligibility was determined during a screening phase of 2 to 42 days. Patients receiving oral treatment with an antipsychotic other than non-generic aripiprazole entered Phase 1. Patients with a lapse in aripiprazole or other antipsychotic treatment at the time of study entry ("lapse" defined as > 3 consecutive days without medication) entered directly into Phase 2. During Phase 1 (oral conversion), patients were cross-titrated during weekly visits from other antipsychotics to oral non-generic aripiprazole monotherapy over a minimum of 4 weeks and a maximum of 6 weeks. During Phase 2 (a minimum of 4 weeks and a maximum of 12 weeks in duration), patients were assessed bi-weekly and stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria were met in Phase 2, patients entered the single-blind aripiprazole intramuscular (IM) depot stabilization phase, Phase 3. In Phase 3, patients were stabilized on aripiprazole IM depot for 12 consecutive weeks. Once the patient met the stability criteria, they were eligible to be randomized into the double-blind phase, Phase 4. Patients were randomized in a 2:1 ratio (aripiprazole IM depot vs placebo IM depot) stratified by region and last aripiprazole IM depot injection dose level in Phase 3. During Phase 4, patients were assessed for impending relapse/exacerbation of psychotic symptoms. If a patient was identified with impending relapse/exacerbation of psychotic symptoms, they were withdrawn from the trial and given the opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248. Patients that completed Phase 4 (up to and including Week 52) had the option to enroll into an open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549).

• Study Type: Interventional
• Enrollment (Actual): 843
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1405BOA
    • Otsuka Investigational Site
  • Buenos Aires, Argentina, C1425AHQ
    • Otsuka Investigational Site
  • Cordoba, Argentina, X5009BIN
    • Otsuka Investigational Site
  • Mendoza, Argentina, 5500HYF
    • Otsuka Investigational Site
  • Mendoza, Argentina, 5500
    • Otsuka Investigational Site
  • Buenos Aires
    • Ciudad Autónoma de Bs. As., Buenos Aires, Argentina, C1058AAJ
      • Otsuka Investigational Site
    • La Plata, Buenos Aires, Argentina, 1900
      • Otsuka Investigational Site
    • Lanús Este, Buenos Aires, Argentina, B1834IBR
      • Otsuka Investigational Site
  • Cordoba
    • Pueyrredón, Cordoba, Argentina, X5004ALB
      • Otsuka Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Otsuka Investigational Site
• Bulgaria
  • Lovech, Bulgaria, 5500
    • Otsuka Investigational Site
  • Pleven, Bulgaria, 5800
    • Otsuka Investigational Site
  • Plovdiv, Bulgaria, 4002
    • Otsuka Investigational Site
  • Radnevo, Bulgaria, 6260
    • Otsuka Investigational Site
  • Region of Veliko Tarnovo, Bulgaria, 5047
    • Otsuka Investigational Site
  • Rousse, Bulgaria, 7000
    • Otsuka Investigational Site
  • Sofia, Bulgaria, 1113
    • Otsuka Investigational Site
  • Varna, Bulgaria, 9010
    • Otsuka Investigational Site
• India
  • Kanpur, India, 208005
    • Otsuka Investigational Site
  • Mangalore, India, 575018
    • Otsuka Investigational Site
  • Pune, India, 411004
    • Otsuka Investigational Site
  • Tirupati, India, 517507
    • Otsuka Investigational Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • Otsuka Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Otsuka Investigational Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600003
      • Otsuka Investigational Site
• Malaysia
  • Selangor, Malaysia, 43000
    • Otsuka Investigational Site
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Otsuka Investigational Site
  • Perak
    • Tanjong Rambutan, Perak, Malaysia, 31250
      • Otsuka Investigational Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
      • Otsuka Investigational Site
• Mexico
  • San Luis Potosí, Mexico, 78218
    • Otsuka Investigational Site
  • DF
    • Mexico, DF, Mexico, 6700
      • Otsuka Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Otsuka Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64040
      • Otsuka Investigational Site
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Otsuka Investigational Site
• Philippines
  • Cebu City, Philippines, 6000
    • Otsuka Investigational Site
  • Central Luzon
    • Bataan, Central Luzon, Philippines, 2105
      • Otsuka Investigational Site
  • NCR
    • Mandaluyong, NCR, Philippines, 1553
      • Otsuka Investigational Site
    • Quezon City, NCR, Philippines, 1104
      • Otsuka Investigational Site
  • Western Visayas
    • Iloilo, Western Visayas, Philippines, 5000
      • Otsuka Investigational Site
• Romania
  • Arad, Romania, 310022
    • Otsuka Investigational Site
  • Bucuresti, Romania, 041914
    • Otsuka Investigational Site
  • Cluj-Napoca, Romania, 400012
    • Otsuka Investigational Site
  • Craiova, Romania, 200620
    • Otsuka Investigational Site
  • Oradea, Romania, 410154
    • Otsuka Investigational Site
  • Pitesti, Romania, 110069
    • Otsuka Investigational Site
• Russian Federation
  • Lipetsk, Russian Federation, 399083
    • Otsuka Investigational Site
  • Moscow, Russian Federation, 115409
    • Otsuka Investigational Site
  • Moscow, Russian Federation, 115522
    • Otsuka Investigational Site
  • Moscow, Russian Federation, 127473
    • Otsuka Investigational Site
  • Nizhny Novgorod, Russian Federation, 603107
    • Otsuka Investigational Site
  • Nizhny Novgorod, Russian Federation, 603155
    • Otsuka Investigational Site
  • Smolensk, Russian Federation, 214019
    • Otsuka Investigational Site
  • St. Petersburg, Russian Federation, 188357
    • Otsuka Investigational Site
  • St. Petersburg, Russian Federation, 190121
    • Otsuka Investigational Site
  • St. Petersburg, Russian Federation, 192019
    • Otsuka Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Otsuka Investigational Site
  • Kragujevac, Serbia, 34000
    • Otsuka Investigational Site
• Slovakia
  • Kosice, Slovakia, 041 90
    • Otsuka Investigational Site
  • Liptovský Mikuláš, Slovakia, 031 23
    • Otsuka Investigational Site
  • Presov, Slovakia, 081 81
    • Otsuka Investigational Site
  • Rimavská Sobota, Slovakia, 979 12
    • Otsuka Investigational Site
  • Svidnik, Slovakia, 089 01
    • Otsuka Investigational Site
• Taiwan
  • Changhua, Taiwan, 500
    • Otsuka Investigational Site
  • Hualien, Taiwan, 981
    • Otsuka Investigational Site
  • Tainan, Taiwan, 704
    • Otsuka Investigational Site
  • Taipei, Taiwan, 110
    • Otsuka Investigational Site
  • Taipei, Taiwan, 112
    • Otsuka Investigational Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85226
      • Otsuka Investigational Site
  • California
    • Anaheim, California, United States, 92805
      • Otsuka Investigational Site
    • National City, California, United States, 91950
      • Otsuka Investigational Site
    • Oceanside, California, United States, 92056
      • Otsuka Investigational Site
    • San Diego, California, United States, 92123
      • Otsuka Investigational Site
    • Santa Ana, California, United States, 92701
      • Otsuka Investigational Site
  • Colorado
    • Highlands Ranch, Colorado, United States, 80130
      • Otsuka Investigational Site
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Otsuka Investigational Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Otsuka Investigational Site
    • Bradenton, Florida, United States, 34208
      • Otsuka Investigational Site
    • Hollywood, Florida, United States, 33021
      • Otsuka Investigational Site
    • Maitland, Florida, United States, 32751
      • Otsuka Investigational Site
    • Miami, Florida, United States, 33135
      • Otsuka Investigational Site
    • North Miami, Florida, United States, 33161
      • Otsuka Investigational Site
    • Orange City, Florida, United States, 32763
      • Otsuka Investigational Site
    • Tampa, Florida, United States, 33613
      • Otsuka Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Otsuka Investigational Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Otsuka Investigational Site
  • Indiana
    • Munster, Indiana, United States, 46321
      • Otsuka Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Otsuka Investigational Site
    • Baton Rouge, Louisiana, United States, 70809
      • Otsuka Investigational Site
    • Lake Charles, Louisiana, United States, 70601
      • Otsuka Investigational Site
    • New Orleans, Louisiana, United States, 70115
      • Otsuka Investigational Site
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Otsuka Investigational Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Otsuka Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63118
      • Otsuka Investigational Site
  • Nebraska
    • North Platte, Nebraska, United States, 69101
      • Otsuka Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Otsuka Investigational Site
  • New York
    • Buffalo, New York, United States, 14215
      • Otsuka Investigational Site
    • Cedarhurst, New York, United States, 11516
      • Otsuka Investigational Site
    • Elmsford, New York, United States, 10523
      • Otsuka Investigational Site
    • Holliswood, New York, United States, 11423
      • Otsuka Investigational Site
    • Jamaica, New York, United States, 11418
      • Otsuka Investigational Site
    • Staten Island, New York, United States, 10305
      • Otsuka Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Otsuka Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Otsuka Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19131
      • Otsuka Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Otsuka Investigational Site
  • Texas
    • Austin, Texas, United States, 78754
      • Otsuka Investigational Site
    • DeSoto, Texas, United States, 75115
      • Otsuka Investigational Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Otsuka Investigational Site
    • Bothell, Washington, United States, 98011
      • Otsuka Investigational Site
    • Richland, Washington, United States, 99354
      • Otsuka Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by the Institutional Review Board/Institutional Ethics Committee [IRB/IEC]), prior to the initiation of any protocol-required procedures.
• Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
• Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening.
• Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
• Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete patient-reported outcomes measures; and who can be reliably rated on assessment scales.

Exclusion Criteria:

• Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
• Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
• Subjects who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine; or 2 positive drug screens for cocaine.
• Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones; or hypersensitivity to antipsychotic agents.
• Subjects with uncontrolled thyroid function abnormalities.
• Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments.
• Subjects who are involuntary incarcerated.
• Subjects who have used an investigational agent within 30 days of screening or prior participation in a clinical study with aripiprazole IM depot.
• Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results; and subjects hospitalized for more than 30 days in the 90 days prior to Phase 1.
• Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [MAOI}), and mood stabilizers during screening and/or Phase 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aripiprazole depot; Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.	Drug: Aripiprazole depot; Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.; Other Names: Abilify
Placebo Comparator: Placebo depot; Patients received placebo intramuscularly every 28 days for 52 weeks.	Drug: Placebo depot; Placebo depot was supplied in 400 mg lyophilized vials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Exacerbation of Psychotic Symptoms/Impending Relapse	A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.	Baseline of the depot maintenance phase to the end of the study (Week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria	This is the key secondary Outcome Measure.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Percentage of Responders	A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Percentage of Patients Achieving Remission	A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).	Baseline of the depot maintenance phase to the end of the study (Week 52)
Mean Change From Baseline in the PANSS Total Score	The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score	The severity of illness for each patient was rated using the CGI-S. 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 patient at this time?" Response choices included: 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 patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Mean Change From Baseline in the PANSS Positive Subscale Score	The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Mean Change From Baseline in the PANSS Negative Subscale Score	The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Mean Clinical Global Impression-Improvement (CGI-I) Score	The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient's condition at Baseline. Response choices included: 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. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.	Baseline of the depot maintenance phase to the end of the study (Week 52)
Time to Discontinuation	Time to discontinuation was defined as the date of randomization to the date of study discontinuation.	Baseline of the depot maintenance phase to the end of the study (Week 52)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Study Director: Raymond Sanchez, MD, Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

General Publications

• Kane JM, Sanchez R, Perry PP, Jin N, Johnson BR, Forbes RA, McQuade RD, Carson WH, Fleischhacker WW. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012 May;73(5):617-24. doi: 10.4088/JCP.11m07530.
• Kane JM, Sanchez R, Baker RA, Eramo A, Peters-Strickland T, Perry PP, Johnson BR, Tsai LF, Carson WH, McQuade RD, Fleischhacker WW. Patient-Centered Outcomes with Aripiprazole Once-Monthly for Maintenance Treatment in Patients with Schizophrenia: Results From Two Multicenter, Randomized, Double-Blind Studies. Clin Schizophr Relat Psychoses. 2015 Summer;9(2):79-87. doi: 10.3371/CSRP.KASA.022015. Epub 2015 Feb 24.
• Fleischhacker WW, Sanchez R, Johnson B, Jin N, Forbes RA, McQuade R, Baker RA, Carson W, Kane JM. Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia. Int Clin Psychopharmacol. 2013 Jul;28(4):171-6. doi: 10.1097/YIC.0b013e3283615dba.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: June 24, 2008
• First Submitted That Met QC Criteria: June 25, 2008
• First Posted (Estimate): June 26, 2008

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: June 16, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Schizophrenia; Aripiprazole; Intramuscular (IM) depot
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 31-07-246