A Phase 4 interventional study of Paliperidone Palmitate in SCHIZOPHRENIA 1 (Disorder), sponsored by Alejandro Alva. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Alejandro Alva · Phase 4, Interventional, and Treatment
This is a prospective, multicenter, open-label, single-arm study evaluating ERZOFRI (paliperidone palmitate) 351 mg administered every 4 weeks as maintenance treatment in approximately 40 adults with schizophrenia who experience symptom worsening before their next scheduled monthly injection despite receiving paliperidone palmitate 234 mg every 4 weeks.
Participants will receive ERZOFRI 351 mg on Day 1, Week 4, and Week 8 and will complete an end-of-study assessment at Week 12. The study will evaluate changes in clinical severity over 12 weeks and will also assess movement-related side effects and sexual functioning.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 40 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with Alejandro Alva as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ERZOFRI 351 mg by intramuscular injection on Day 1, Week 4, and Week 8, followed by an end-of-study assessment at Week 12.
Drug: Paliperidone Palmitate
Paliperidone palmitate extended-release injectable suspension (ERZOFRI) 351 mg administered by intramuscular injection on Day 1, Week 4, and Week 8. The Day 1 injection will be administered in the deltoid muscle; subsequent injections may be administered in the deltoid or gluteal muscle.
Also known as: ERZOFRI
Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Score
Change in clinician-rated CGI-S score from Baseline (Day 1) to Week 12. The CGI-S is a 7-point scale assessing overall severity of mental illness, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Negative changes from baseline indicate improvement.
Time frame: Baseline (Day 1) and Week 12
Patient Clinical Global Impression-Improvement (PCGI-I) Response
Proportion of participants reporting a PCGI-I score ≤2 ("much improved" or "very much improved"). The PCGI-I is a 7-point patient-reported measure of perceived global improvement, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
Time frame: Weeks 4, 8, and 12
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Change from baseline in total SAS score. The SAS is a 10-item clinician-rated scale assessing parkinsonian signs. Each item is scored from 0 (normal) to 4 (extreme), with total scores ranging from 0 to 40; higher scores indicate greater severity of parkinsonian symptoms.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Items 1-7 Total Score
Change from baseline in the total score for AIMS Items 1-7. The AIMS is a clinician-rated scale assessing involuntary movements involving the facial/oral regions, extremities, and trunk. Items 1-7 are each scored from 0 (none) to 4 (severe), with higher scores indicating greater severity of involuntary movements. The total score for Items 1-7 ranges from 0 to 28.
Time frame: Baseline, Week 4, Week 8, and Week 12
Correlation Between Serum Prolactin Concentration and Arizona Sexual Experience Scale (ASEX) Total Score
Correlation between serum prolactin concentration (ng/mL) and sexual dysfunction assessed using the Arizona Sexual Experience Scale (ASEX) at Week 12. The ASEX is a five-item questionnaire with total scores ranging from 5 to 30; higher scores indicate greater sexual dysfunction. The relationship will be evaluated using Pearson or Spearman correlation coefficients, as appropriate.
Time frame: Week 12
Clinical Global Impression-Improvement (CGI-I) Response
Proportion of participants achieving a CGI-I score ≤2 ("much improved" or "very much improved"). The CGI-I is a 7-point clinician-rated scale assessing overall clinical improvement relative to baseline, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
Time frame: Weeks 4, 8, and 12
Change From Baseline in Arizona Sexual Experience Scale (ASEX) Total Score
Change from baseline in ASEX total score at Weeks 4, 8, and 12. The ASEX is a five-item questionnaire assessing sexual functioning, with total scores ranging from 5 to 30. Higher scores indicate greater sexual dysfunction.
Time frame: Baseline, Weeks 4, 8, and 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants experiencing treatment-emergent adverse events during the study, with adverse event severity summarized.
Time frame: Day 1 through Week 12
Change From Screening to Week 12 in Serum Prolactin Concentration
Change in serum prolactin concentration (ng/mL) from Screening to Week 12 during treatment with ERZOFRI 351 mg Q4W.
Time frame: Screening and Week 12
Mean Change From Baseline in Fasting Glucose
Change from baseline to Week 12 in fasting blood glucose concentration, measured in mg/dL.
Time frame: Baseline and Week 12
Injection-Site Pain Severity Score
Severity of injection-site pain following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate greater severity.
Time frame: Day 1, Weeks 4 and 8
Mean Change From Baseline in QTcF Interval
Change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds (ms), as assessed by 12-lead electrocardiogram (ECG).
Time frame: Baseline, Weeks 4, 8, and 12
All-Cause Study Discontinuation
Number and proportion of participants who discontinue the study before Week 12, with reasons for discontinuation summarized.
Time frame: Day 1 through Week 12
Symptom Breakthrough Before the 4-Week Injection Interval
Proportion of participants experiencing symptom breakthrough before the scheduled 4-week injection interval during the study period, compared with their documented pre-enrollment rate of symptom breakthrough.
Time frame: Day 1 through Week 12
Number of Unscheduled Clinic Visits for Psychiatric Symptoms
Total number of unscheduled clinic visits related to psychiatric symptoms occurring during the 12-week study period.
Time frame: Day 1 through Week 12
Mean Change From Baseline in Body Weight
Change from baseline to Week 12 in body weight, measured in kilograms (kg).
Time frame: Baseline and Week 12
Mean Change From Baseline in Body Mass Index (BMI)
Change from baseline to Week 12 in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline and Week 12
Mean Change From Baseline in Waist Circumference
Change from baseline to Week 12 in waist circumference, measured in centimeters (cm).
Time frame: Baseline and Week 12
Mean Change From Baseline in Total Cholesterol
Change from baseline to Week 12 in serum total cholesterol concentration, measured in mg/dL.
Time frame: Baseline and Week 12
Mean Change From Baseline in HDL Cholesterol
Change from baseline to Week 12 in high-density lipoprotein (HDL) cholesterol concentration, measured in mg/dL.
Time frame: Baseline and Week 12
Mean Change From Baseline in LDL Cholesterol
Change from baseline to Week 12 in low-density lipoprotein (LDL) cholesterol concentration, measured in mg/dL.
Time frame: Baseline and Week 12
Mean Change From Baseline in Triglycerides
Change from baseline to Week 12 in serum triglyceride concentration, measured in mg/dL.
Time frame: Baseline and Week 12
Injection-Site Swelling Severity Score
Severity of injection-site swelling following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no swelling) to 10 (most severe swelling). Higher scores indicate greater severity.
Time frame: Day 1, Weeks 4 and 8
Injection-Site Redness Severity Score
Severity of injection-site redness following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no redness) to 10 (most severe redness). Higher scores indicate greater severity.
Time frame: Day 1, Weeks 4 and 8
Number of Emergency Department Visits for Psychiatric Symptoms
Total number of emergency department visits related to psychiatric symptoms occurring during the 12-week study period.
Time frame: Day 1 through Week 12
Number of Psychiatric Hospitalizations
Total number of psychiatric hospitalizations occurring during the 12-week study period.
Time frame: Day 1 through Week 12
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 71 non-industry phase 4 interventional studies under Schizophrenia, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 64. This study's planned 12 months is below that.
Counting every sponsor, half of 88 studies reached it within 39 months; a quarter within 20 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Paliperidone