Trial Outcomes & Findings for A Study of Cariprazine in Patients With Chronic Stable Schizophrenia (NCT NCT00839852)

Last Updated: 2019-08-22

Results Overview

The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Baseline to Week 48

Results posted on

2019-08-22

Participant Flow

The Enrolled Population consisted of 97 participants who completed the lead-in study, RGH-MD-16, and signed an informed consent form to continue in this extension study. The Safety Population consisted of 93 participants from the Enrolled Population who took at least 1 dose of cariprazine in this extension study.

The study was designed as a one-arm study where patients were not randomized or analyzed by dose, rather they were flexibly dosed with Cariprazine 1.5, 3.0, or 4.5 mg/day via oral administration. The starting dose of 1.5 mg/day was titrated as needed within the range of 1.5-4.5 mg/d based on investigator's judgment of response and tolerability.

Participant milestones

Participant milestones
Measure	Cariprazine Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Overall Study STARTED	93
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Cariprazine Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Overall Study Adverse Event	10
Overall Study Insufficient Therapeutic Response	3
Overall Study Protocol Violation	9
Overall Study Withdrawal of Consent	16
Overall Study Lost to Follow-up	7
Overall Study Lack of Compliance While in Jail	1
Overall Study Pregnancy	1

Baseline Characteristics

A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cariprazine n=93 Participants Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Age, Continuous	34.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Weight	72.19 kg STANDARD_DEVIATION 17.66 • n=5 Participants
Height	169.09 cm STANDARD_DEVIATION 10.73 • n=5 Participants
Body Mass Index (BMI)	24.99 kg/m^2 STANDARD_DEVIATION 4.46 • n=5 Participants
Waist circumference	84.90 cm STANDARD_DEVIATION 11.19 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 48

Population: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.

Outcome measures

Outcome measures
Measure	Cariprazine n=92 Participants Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Change From Baseline to Week 48 in the PANSS Total Score	-38.5 Units on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.

The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Cariprazine n=92 Participants Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Change From Baseline to Week 48 in the CGI-S Score	-2.0 Units on a scale Standard Error 0.1

Adverse Events

Cariprazine

Serious events: 12 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cariprazine n=93 participants at risk Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Psychiatric disorders Schizophrenia	4.3% 4/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Psychotic disorder	2.2% 2/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Renal and urinary disorders Adjustment disorder	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Agitation	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Completed suicide	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Respiratory, thoracic and mediastinal disorders Asthma	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Social circumstances Social stay hospitalisation	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Infections and infestations Filariasis	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Infections and infestations Orchitis	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Injury, poisoning and procedural complications Alcohol poisoning	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Injury, poisoning and procedural complications Intentional overdose	1.1% 1/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.

Other adverse events

Other adverse events
Measure	Cariprazine n=93 participants at risk Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Gastrointestinal disorders Constipation	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Gastrointestinal disorders Diarrhoea	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Gastrointestinal disorders Dyspepsia	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
General disorders Fatigue	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Infections and infestations Nasopharyngitis	8.6% 8/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Investigations Weight increased	11.8% 11/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Akathisia	14.0% 13/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Headache	8.6% 8/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Dizziness	7.5% 7/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Tremor	7.5% 7/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Extrapyramidal disorder	6.5% 6/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Sedation	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Nervous system disorders Somnolence	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Insomnia	14.0% 13/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Agitation	7.5% 7/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Anxiety	7.5% 7/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.
Psychiatric disorders Psychotic disorder	5.4% 5/93 • Baseline to Week 52 Safety population: All enrolled participants who took at least 1 dose of cariprazine.

Additional Information

Willie R. Earley, MD Associate Vice President Clinical Development-CNS

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Publication restrictions are in place

Restriction type: OTHER