Clinical, for clinicians
Five antipsychotics profiled from their FDA labels, the Sensus readings that matter for each, and a map from a person’s answers to the points a prescriber may want to discuss with them.
What this adds up to
People stop treatment for reasons that can be measured. Sensus measures them every four weeks, in the person’s own words and a family member’s, and puts them in front of the clinician, so the conversation about a medicine can happen before the decision to stop it.
A psychiatrist’s ideal assessment of schizophrenia combines a diagnostic interview, a mental status examination, clinician-rated symptom scales, cognitive testing, a functional measure and laboratory work. Sensus is built to match that battery’s quality between visits, and to sit beside it, not replace it. The preferred option in each row is marked; where each is better at a different job, both are.
| What is assessed | Clinic gold standard | Publicly available? | Sensus choice | Publicly available? | The difference |
|---|---|---|---|---|---|
| Diagnosis | Preferred SCID-5, the structured clinical interview for DSM-5 | No: licensed (APA Publishing); trained interviewer | Background intake and M3 Checklist; the clinician records the diagnosis | Intake and M3: ours | The SCID-5 walks through every DSM-5 criterion in a structured interview to confirm the diagnosis and rule out others. Sensus does not diagnose. It records when symptoms began, how they have run since and the mood picture beside them, which the interview otherwise has to rebuild from memory. |
| Mental status | Preferred Mental Status Examination | A clinical method, not an instrument | Clinician entry at visits | — | The MSE rests on what the clinician observes: appearance, speech, behaviour, thought form. A questionnaire cannot see these, so Sensus only records the clinician’s findings. |
| Positive symptoms | Preferred at visitsPANSS, 30 items, clinician-rated | No: licensed (Mapi Research Trust) | Preferred between visitsColorado Symptom Index (14) and R-GPTS paranoia (18), self-report; the clinician’s PANSS total recorded | CSI and R-GPTS: free public sources, written confirmation pending | The PANSS is an interview covering positive, negative and general symptoms, and it defines remission and treatment response. CSI and R-GPTS are self-report: R-GPTS is highly accurate for paranoia (AUC 0.953), but neither covers disorganized thinking, which needs an observer. Use PANSS at visits, CSI and R-GPTS between them. |
| Negative symptoms | Preferred CAINS, clinician interview | Free for research only (Kring lab) | MAP-SR (15), self-report, built to mirror the CAINS motivation and pleasure scale | Permission to be requested | The CAINS rates both motivation and pleasure and expression (blunted face, voice, gesture), which needs an observer. The MAP-SR covers only motivation and pleasure, correlating r = 0.65 with the matching CAINS scale. |
| Depression vs negative symptoms | Preferred Calgary Depression Scale (CDSS), 9 items, clinician interview | Free for clinicians in routine practice; other uses via Mapi | M3 depression module read beside the MAP-SR; the clinician’s CDSS recorded | M3: ours | The CDSS was built to separate depression from negative symptoms in schizophrenia and is not meant for self-assessment. The M3 is not validated for that distinction. Sensus places the two side by side and flags the question for the clinician. |
| Cognition | Preferred BACS or MCCB, trained tester | No: licensed | Clinician-entered score; smartphone tasks under evaluation | Clinician entry; home tasks exploratory | The BACS and MCCB are timed, standardized tests given by a trained tester; the MCCB is the outcome standard for cognition trials. Home smartphone tasks correlate r = 0.53–0.60 with the MCCB and are not yet a substitute. |
| Function | WHODAS 2.0, given in the clinic | Free for clinicians with their own patients; electronic use needs WHO permission | Preferred The same WHODAS 2.0, 12-item, from the person and a family member, every quarter | WHO permission pending | The identical instrument. Sensus adds the family version, which is the more sensitive to change in serious mental illness, and repeats it every twelve weeks instead of at occasional visits. |
| Medical mimics | CBC, TSH, liver and renal panels, vitamin levels | Standard laboratory tests | Preferred The same tests, entered by the clinician, with reminders when due | Ours | The same tests. Sensus adds the timeline and the reminders: the ADA/APA metabolic timetable and the clozapine ANC schedule. |
| Substance use | Preferred recent useToxicology screen | Standard laboratory test | Preferred pattern over timeTAPS Tool, self-report, every quarter | Public domain (NIDA) | A urine screen objectively shows recent drug use, but not alcohol patterns, tobacco or prescription misuse. TAPS covers those and the pattern over time, but relies on what the person reports. Each covers what the other misses. |
The ideal clinic list has no measure of what the treatment costs the person, whether they are taking it, or how they see it, which are the main reasons people stop.9 Sensus adds:
| Added by Sensus | Instrument | Publicly available? | Why it matters |
|---|---|---|---|
| Side-effects | GASS (22), self-report | Yes: freely available (PhenX Toolkit) | Antipsychotics differ more in side-effects than in efficacy |
| Pain | DVPRS (5) | US federal work, free unaltered | About a third of people with schizophrenia live with clinical pain |
| Sleep | PROMIS Sleep Disturbance 8a | Permission pending (HealthMeasures) | A common symptom and a common side-effect |
| Insight | VAGUS-SR (10) | Licence pending (CAMH) | Lack of insight is the most-reported driver of stopping |
| Adherence and life events | M3’s own questions | Ours | No conclusion about a medicine can be drawn if it is not being taken |
| Safety | M3 item 5 and the 988 pathway | Ours | Fires at every sitting, between visits, when no clinician is present |
Every need the two lists address, side by side. The clinic list is the gold-standard battery above; the Sensus list is what Sensus gives today. The two are strongest together: the clinic list for diagnosis and what only an observer can rate, Sensus for the months between visits and the reasons people stop.
| Need or symptom | Clinic gold-standard list | Sensus list |
|---|---|---|
| Diagnosis and what is observed | ||
| Confirming the diagnosis | Yes SCID-5 | No Records the clinician’s diagnosis |
| Observed mental state (appearance, speech, thought form) | Yes Mental Status Examination | No Records the clinician’s findings |
| Psychotic symptoms | ||
| Hearing voices and other hallucinations | Yes PANSS | Yes CSI, every 4 weeks |
| Delusions and unusual beliefs | Yes PANSS | Partly CSI items; no dedicated scale |
| Paranoia and suspiciousness | Partly PANSS, one item | Yes R-GPTS (18 items) and CSI |
| Disorganized thinking | Yes PANSS; MSE | No Needs an observer |
| Negative symptoms | ||
| Motivation and pleasure | Yes CAINS; PANSS | Yes MAP-SR, quarterly |
| Blunted expression (face, voice, gesture) | Yes CAINS; PANSS | No Needs an observer |
| Mood, anxiety and safety | ||
| Depression | Yes Calgary Depression Scale | Yes M3 depression module |
| Telling depression apart from negative symptoms | Yes Calgary Depression Scale | Partly M3 beside MAP-SR; flagged for the clinician |
| Bipolar signs and mania | Partly SCID-5 mood modules; PANSS excitement item | Yes M3 bipolar module, every 4 weeks |
| Anxiety | Partly SCID-5; PANSS anxiety item | Yes M3 anxiety module |
| PTSD | Partly SCID-5, if the module is given | Yes M3 PTSD items |
| OCD symptoms | Partly SCID-5, if the module is given | Partly M3 OCD items (3) |
| Suicidal thoughts | Partly Calgary item; asked at visits | Yes M3 and CSI at every sitting, with the 988 pathway |
| Safety check between visits | No | Yes Every 4 weeks, at home |
| Thinking and awareness | ||
| Cognition (memory, attention, speed) | Yes BACS or MCCB | No Records the clinician’s score |
| Insight into the illness and treatment | Partly PANSS, one item | Yes VAGUS-SR, quarterly |
| Everyday life | ||
| Function, the person’s view | Yes WHODAS 2.0 | Yes WHODAS 2.0, quarterly |
| Function, a family member’s view | No | Yes WHODAS 2.0 family version |
| Personal goals | No | Yes Up to 3, rated every 4 weeks |
| Life events beside the scores | No | Yes Every 4 weeks |
| Body and treatment | ||
| Medicine side-effects | No | Yes GASS (22 items) |
| Movement side-effects | No Not in the list (AIMS exam) | Partly GASS movement items |
| Pain | No | Yes DVPRS |
| Sleep | No | Yes PROMIS Sleep |
| Taking the medicine (adherence) | No | Yes Every 4 weeks, with reasons |
| Therapy and support received | No | Yes Sessions by kind, every 4 weeks |
| Medical causes ruled out (labs) | Yes CBC, TSH, liver, renal, vitamins | Yes Same labs, clinician-entered, with reminders |
| Weight and metabolic monitoring on schedule | Partly Labs, no timetable | Yes NICE and ADA/APA timetable per medicine |
| Context | ||
| Recent drug use, objectively | Yes Toxicology screen | No |
| Alcohol, tobacco and drug use over time | Partly SCID-5 substance module | Yes TAPS, quarterly |
| Needs covered, of 32 | 13 fully, 9 partly, 10 not covered | 22 fully, 4 partly, 6 not covered |
| Total questions | 64 rated items (PANSS 30, CAINS 13, Calgary 9, WHODAS 12), plus the SCID-5 interview, the MSE, 6 BACS tests (or 10 MCCB tests), labs and a drug screen | About 90 answers every 4 weeks (M3 27, CSI 14, GASS 21 of 22 by sex, PROMIS 8, DVPRS 5, about 15 on medicine, therapy, life and goals). About 42 more each quarter (WHODAS 12, MAP-SR 15, VAGUS 10, TAPS 5), plus R-GPTS 18 when asked and 12 for a family member |
| Who gives it, and how long | Trained clinicians and testers; roughly 2½ to 4 hours of clinician time in total (SCID-5 60–90 min, PANSS 30–50, CAINS 15–30, Calgary 10–15, BACS about 35) | The person, at home; about 20 minutes every 4 weeks and about 15 more each quarter. No clinician time to give it |
Partly means the need is touched by one item or only for some people (for example a SCID-5 module given only when indicated). Item counts are those of the published instruments; times are typical published ranges. Planned additions would close more of the gaps: the PANSS-6 between visits by a clinician for disorganized thinking, delusions and blunted expression, and the SNS self-report for all five negative-symptom areas.
| Standard | Clinic gold-standard battery | Sensus |
|---|---|---|
| Quality | The reference standard for diagnosis and symptom severity | Published, validated instruments, used unaltered; strongest for paranoia, function and insight. Several have not yet been studied for repeated use, and each is labelled |
| Utility | Establishes the diagnosis and a baseline at one point in time | Shows direction between visits, linked to each medicine’s trial window, side-effects and adherence |
| Compactness | Several interviews and tests, each needing a trained clinician or rater | About 20 minutes every four weeks, about 15 more each quarter, answered at home |
| Engagement | None between visits | Life events, personal goals and a report the person keeps |
| Efficiency | Clinician time at every administration | No clinician time to administer; the clinician reviews one overview and adds their own ratings |
Two new agents, the treatment-resistance standard, and two widely used comparators. Each card uses the same fields so they can be read side by side.
| Mechanism | Muscarinic agonist (xanomeline) with a peripherally acting muscarinic antagonist (trospium). Does not block dopamine receptors. |
|---|---|
| FDA status | Approved 26 September 2024, schizophrenia in adults1 |
| Form | Oral capsule, twice daily |
| Boxed warning | None2 |
| Most common | Nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia |
| Warnings | Urinary retention; hepatic impairment; biliary disease; decreased GI motility; angioedema; narrow-angle glaucoma; increased heart rate; anticholinergic effects in renal impairment; CNS effects |
| Contraindicated | Urinary retention; moderate or severe hepatic impairment; gastric retention; untreated narrow-angle glaucoma; hypersensitivity |
| Interaction classes | Strong CYP2D6 inhibitors; drugs eliminated by tubular secretion; sensitive CYP3A4 and P-gp substrates; antimuscarinics |
| Not in the label | Tardive dyskinesia, NMS, metabolic changes and the dementia boxed warning are not among its warnings2 |
Sensus watches: GI symptoms and urinary hesitancy (GASS); heart racing; blood pressure (clinician entry).
| Mechanism | D2, 5-HT2A and strong alpha-1 antagonism; interconverts with iloperidone |
|---|---|
| FDA status | Approved 20 February 2026, schizophrenia and acute mania or mixed episodes of bipolar I in adults3 |
| Form | Oral tablet, with a titration period |
| Boxed warning | Increased mortality in elderly patients with dementia-related psychosis |
| Most common | Dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, weight increased |
| Warnings | QTc prolongation; NMS; tardive dyskinesia; metabolic changes; orthostatic hypotension and syncope; seizures; leukopenia, neutropenia and agranulocytosis; priapism; floppy iris syndrome; falls; hyperprolactinemia |
| Before starting | The label advises considering CYP2D6 genetic testing; not recommended in severe hepatic impairment |
| Interaction classes | Strong CYP2D6 and CYP3A4 inhibitors; other QTc-prolonging drugs; alpha-blockers and other blood-pressure drugs |
Sensus watches: dizziness on standing, fainting and falls; heart racing; weight; prolactin-related items (GASS).
| Indications | Severely ill schizophrenia not responding to standard treatment; reducing the risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorder4 |
|---|---|
| Form | Oral tablet or orally disintegrating tablet |
| Boxed warnings | Severe neutropenia; orthostatic hypotension, bradycardia and syncope; seizure; myocarditis, pericarditis and cardiomyopathy; dementia-related mortality |
| Most common | Sedation, dizziness, headache, tremor; tachycardia, hypotension, syncope; hypersalivation, sweating, dry mouth, visual disturbance; constipation, nausea; fever |
| Other warnings | GI hypomotility; QT prolongation; metabolic changes; NMS; hepatotoxicity; tardive dyskinesia; and others |
| Monitoring | ANC at baseline and on the schedule in the label. The FDA removed the clozapine REMS effective 13 June 2025; monitoring continues per the label5 |
| Interaction note | Smoking affects clozapine levels; a change in smoking is worth recording |
Sensus watches: constipation and salivation (GASS); sedation; fever; dizziness; tobacco use (TAPS); ANC due dates.
| Indications | Schizophrenia; acute manic and mixed episodes of bipolar I; others17 |
|---|---|
| Form | Oral daily; long-acting injectable forms available |
| Boxed warnings | Dementia-related mortality; suicidality in young people (antidepressant class warning) |
| Most common | Akathisia, the main reaction above placebo; also nausea, vomiting, constipation, headache |
| Warnings | NMS; tardive dyskinesia; metabolic changes; compulsive behaviors, including gambling; orthostatic hypotension; leukopenia and neutropenia |
Sensus watches: restlessness (GASS); new compulsive urges, raised in the visit; weight.
| Indications | Schizophrenia; bipolar I, acute and maintenance treatment18 |
|---|---|
| Evidence | In CATIE, olanzapine had the lowest discontinuation (64% vs 74–82%) and the longest time on treatment, with more weight gain and rises in HbA1c, cholesterol and triglycerides7 |
| Form | Oral daily. TEV-'749, a once-monthly subcutaneous injection, is investigational, with an FDA decision expected Q4 2026 |
| TEV-'749 trial data | Weight increase was the commonest adverse event (36%); no post-injection delirium or sedation syndrome in 3,470 injections8 |
| Interaction note | Smoking affects olanzapine levels |
Sensus watches: weight against the window baseline; sedation; the metabolic timetable. See the Medications in Phase 3 schedule.
Taken from each label’s most common reactions, warnings and boxed warnings, and from CATIE for olanzapine. Yes: listed, or shown separately in trials. Mixed: mixed results. Total score: approved on total-score evidence. Indicated or Boxed: a specific indication or a boxed warning. A dash means not listed in the sources cited.
| Signal in the record | Sensus source | Cobenfy | Bysanti | Clozapine | Aripiprazole | Olanzapine |
|---|---|---|---|---|---|---|
| What each medicine was shown to treat | ||||||
| Positive symptoms (voices, paranoia, unusual beliefs) | Senses: CSI, R-GPTS | Yes all 3 trials | Total score | Total score | Total score | Total score |
| Negative symptoms (loss of motivation, pleasure, expression) | MAP-SR; family WHODAS | Mixed 2 of 3 trials | Total score | Total score | Total score | Total score |
| Treatment-resistant schizophrenia | Trial windows; TRRIP note | – | – | Indicated | – | – |
| Also approved for bipolar I (manic or mixed episodes) | M3 bipolar items | – | Yes | – | Yes | Yes |
| What the record watches for | ||||||
| Weight and metabolic change | Weight, glucose, lipids; GASS | – | Yes | Yes | Yes | Yes |
| Restlessness (akathisia) | GASS | – | – | – | Yes | – |
| Involuntary movements (TD) | Clinician exam | – | Yes | Yes | Yes | – |
| Sleepiness | GASS; PROMIS Sleep | – | Yes | Yes | – | Yes |
| Dizziness on standing, fainting, falls | GASS; titration check | Yes | Yes | Boxed | Yes | – |
| Heart racing | GASS; clinician entry | Yes | Yes | Yes | – | – |
| Nausea, constipation, GI slowing | GASS | Yes | – | Yes | Yes | – |
| Urinary hesitancy or retention | GASS | Yes | – | – | – | – |
| Prolactin and sexual effects | GASS | – | Yes | – | – | – |
| Seizure | Urgent question | – | Yes | Boxed | – | – |
| Fever with rigidity or confusion (possible NMS) | Urgent question | – | Yes | Yes | Yes | – |
| Low white cell count | Clinician lab entry | – | Yes | Boxed | Yes | – |
| Heart rhythm (QTc) | Clinician ECG entry | – | Yes | Yes | – | – |
Positive and negative symptoms. Cobenfy improved the PANSS positive subscale in all three of its trials, and the negative subscale in two of the three (EMERGENT-1 and -2, not EMERGENT-3).16 The other four were approved on total symptom scores, which combine positive, negative and general symptoms; a separate effect is not shown in the sources cited. None of the five carries a separate FDA indication for negative symptoms. Bysanti, aripiprazole and olanzapine are also approved for manic or mixed episodes of bipolar I disorder.31718
A dash means the item is not among the reactions and warnings in the sources cited here, not that it never occurs. The olanzapine column reflects CATIE and the TEV-'749 trial only; it will be completed from the olanzapine label before build. Check every cell against the current label.
From the FDA prescribing information for the two approved agents, and from the sponsor for the one still in review. For the clinician only: the person’s report never shows a dose. Always check the current label before prescribing.
| Cobenfy xanomeline and trospium chloride | Bysanti milsaperidone | TEV-'749 olanzapine extended-release injectable suspension | |
|---|---|---|---|
| Status | FDA approved 26 September 2024, schizophrenia in adults1 | FDA approved 20 February 2026, schizophrenia and acute manic or mixed episodes of bipolar I in adults3 | Investigational. NDA accepted 20 February 2026; the sponsor expected an FDA decision in Q4 2026. No approval found as of this build21 |
| Mechanism | Muscarinic agonist with a peripherally acting muscarinic antagonist; no dopamine blockade | Atypical antipsychotic; interconverts with iloperidone | Olanzapine in a once-monthly subcutaneous depot |
| Strengths | Capsules 50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg19 | Tablets 1, 2, 4, 6, 8, 10 and 12 mg20 | Three dose levels studied (low, medium, high); final strengths will come with the label |
| Starting and titration | 50 mg/20 mg twice daily for at least 2 days, then 100 mg/20 mg twice daily for at least 5 days | Schizophrenia: 1, 2, 4, 6, 8, 10, 12 mg twice daily on days 1 to 7. Bipolar I mania: 1, 3, 6, 9, 12 mg twice daily on days 1 to 5. Titration lowers the risk of orthostatic hypotension | Not yet labelled. The sponsor has modelled direct switching from oral olanzapine |
| Maintenance | May increase to 125 mg/30 mg twice daily based on tolerability and response (maximum) | Schizophrenia: 6 to 12 mg twice daily. Bipolar I mania: 12 mg twice daily | Once every four weeks, given by a healthcare professional |
| Adjustments | Geriatric: start 50 mg/20 mg twice daily, consider slower titration, maximum 100 mg/20 mg twice daily. Not recommended in moderate or severe renal impairment, or in mild hepatic impairment; contraindicated in moderate or severe hepatic impairment | CYP2D6 poor metabolizers: shorter titration to 3 to 6 mg twice daily (schizophrenia) or 6 mg twice daily (mania). Reduce the dose with a strong CYP2D6 or CYP3A4 inhibitor. Not recommended in severe hepatic impairment | To come with the label |
| How it is taken | At least 1 hour before or 2 hours after a meal. Do not open the capsules | With or without food. If more than 3 days are missed, restart the titration schedule | Subcutaneous injection. Trials found no post-injection delirium or sedation syndrome, and no evidence of a need for post-injection monitoring821 |
| Most common side-effects | Nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia2 | Dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, weight increased (schizophrenia) | Weight increase was the commonest adverse event (36%)8 |
| Weight and metabolic | No metabolic warning in the label | Weight increased among the common reactions; metabolic changes is a label warning | Olanzapine carries the highest metabolic burden of the comparators in CATIE7 |
| What Sensus adds | The meal-timing rule is a common reason doses go wrong; GI and urinary items on the GASS | Missed days on the adherence question trigger the re-titration reminder; dizziness and falls on the GASS | Injection dates in place of daily adherence; weight against the ADA/APA timetable |
Doses quoted from the FDA prescribing information (Cobenfy, Bysanti) and sponsor materials (TEV-'749). Sensus does not calculate, suggest or display doses to the person.
The late-stage schizophrenia medicines Sensus is ready to follow. Clozapine stays in the medicine list as the treatment-resistance standard. Investigational agents are available only inside clinical trials; timelines are the sponsors’ own and can move.
| Medicine | Company | Where it stands | Mechanism and form | What Sensus would watch |
|---|---|---|---|---|
| TEV-'749 olanzapine LAI | Teva and MedinCell | NDA accepted 20 February 2026; FDA decision expected Q4 202621 | Once-monthly subcutaneous olanzapine (SteadyTeq copolymer). Designed to avoid the 3-hour post-injection observation required for the older intramuscular olanzapine depot | Injection dates in place of daily doses; weight against the NICE and ADA/APA timetable; sedation |
| Bysanti milsaperidone | Vanda Pharmaceuticals | FDA approved 20 February 2026; launch under way3 | Oral tablet, twice daily after titration. Schizophrenia and acute manic or mixed episodes of bipolar I | Missed days (re-titration after more than 3), dizziness and falls, weight, M3 bipolar items |
| NBI-1117568 | Neurocrine Biosciences (from Nxera) | Phase 3 registrational programme started 30 April 202524 | Oral, once daily. M4-selective orthosteric muscarinic agonist; no dopamine blockade. Phase 2: 7.5-point placebo-adjusted PANSS reduction at week 6, generally well tolerated | Positive and negative symptoms (CSI, R-GPTS, MAP-SR); GI items; weight should stay flat |
| LB-102 N-methyl amisulpride | LB Pharmaceuticals | Phase 3 NOVA-2 (about 460 patients); topline results expected first half of 2027, pre-NDA meeting second half of 202725 | Oral, once daily. Selective D2, D3 and 5-HT7 antagonist, a methylated derivative of amisulpride | Prolactin and sexual items on the GASS; restlessness; symptoms |
| KarXT Cobenfy, new uses | Bristol Myers Squibb | Approved for adults 2024. Adjunctive use failed its Phase 3 ARISE primary endpoint (April 2025)26. Adolescent and wider-population trials are reported in market summaries; not confirmed in BMS releases we found | Oral capsule, twice daily. Muscarinic agonist with a peripheral antagonist | As for Cobenfy: meal timing, GI and urinary items, heart rate |
Each has its own switch for the clinician guidance page in Clinical Support Set Up (KarXT shares the Cobenfy switch), alongside clozapine, aripiprazole and oral olanzapine: eight medicines in all.
Each row is a pattern the record can show, what the clinician view displays, and the guideline or label it draws on. Every row ends in a conversation, never an automatic action.
| When the record shows | The clinician view displays | Points for discussion | Anchor |
|---|---|---|---|
| A positive safety answer (M3 suicide item; CSI harm item) | The 988 pathway has already fired for the person. A flag at the top of the report. | Follow the practice’s own safety protocol. Clozapine is FDA-indicated for reducing recurrent suicidal behavior in schizophrenia. | Clozapine label4 |
| Fever with stiffness or confusion; a seizure; priapism | Emergency guidance was shown to the person at once. | Possible NMS or a serious adverse reaction: urgent assessment. | Labels234 |
| Adherence below 80%, or a late or missed injection | Shown first, before any reading of symptoms | Explore the reasons, which are commonly side-effects, beliefs about the medicine and insight. Whether a long-acting injection would suit the person, if they prefer it. | Higashi 20139; NICE CG17810 |
| Symptoms not easing (CSI, R-GPTS) after two or more medicines, each tried for six weeks or more, with adherence of 80% or more | A note that the TRRIP criteria for treatment resistance may be worth assessing | Confirm with a clinician-rated scale. NICE recommends offering clozapine after adequate trials of at least two different antipsychotics, at least one a non-clozapine second-generation agent. | Howes 201712; NICE CG17810 |
| Weight up 5% or more from the window baseline, or glucose or lipids rising | Weight trend with the ADA/APA timetable | The consensus advises considering a switch at 5% or more weight gain. Side-effect profiles differ more than efficacy between agents; Cobenfy’s label carries no metabolic warning. | ADA/APA 200413; Huhn 201914; Cobenfy label2 |
| Restlessness high on the GASS | GASS movement items over time | Possible akathisia. Akathisia is the most common reaction on aripiprazole. Agents differ markedly in movement effects. | Aripiprazole label6; Huhn 201914 |
| Stiffness or tremor, with pain rising on the DVPRS | GASS movement items beside the DVPRS | Examine for movement side-effects, including painful dystonia. An AIMS in the clinic. | Oregon Health Authority 202415 |
| Dizziness on standing, fainting or falls | Titration check and GASS | Orthostatic hypotension, listed for Bysanti and boxed for clozapine. Blood pressure lying and standing. | Labels34 |
| Urinary hesitancy, constipation or nausea on Cobenfy | GASS items, flagged for this agent | Urinary retention and decreased GI motility are label warnings. | Cobenfy label2 |
| Constipation or salivation on clozapine | GASS items, flagged for this agent | GI hypomotility is a label warning. | Clozapine label4 |
| Sleepiness high on the GASS or PROMIS | Sleep and sedation trend | Sedation as a reason for stopping. Timing and agent. | Labels; Higashi 20139 |
| Prolactin or sexual effects on the GASS | GASS items | Prolactin level. Hyperprolactinemia is a Bysanti label warning. | Bysanti label3 |
| Depressive symptoms on the M3 Checklist | M3 depression module trend | Distinguish depression from negative symptoms and from sedation. Mood guidance applies to the depressive component. | CANMAT (mood); NICE CG17810 |
| Bipolar signs on the M3 Checklist | M3 bipolar items | Mood episodes alongside psychosis bear on the schizoaffective and bipolar differential. Bysanti, aripiprazole and olanzapine are also approved for bipolar I mania; Cobenfy and clozapine are not. | CANMAT/ISBD (bipolar); labels31718 |
| Low insight on the VAGUS | Awareness trend | Lack of insight is the most-reported driver of stopping. Involve the family; NICE recommends offering family intervention. | Higashi 20139; NICE CG17810 |
| Function low (WHODAS self and family) while symptoms are steady | Function beside symptoms | Psychosocial treatment: CBT for psychosis, family intervention, supported employment. | NICE CG17810 |
| Loss of motivation and pleasure on the MAP-SR | Negative-symptom trend | Check whether depression, sedation or movement side-effects are contributing before treating it as primary. | Clinical judgement |
| Cannabis or other substance use on the TAPS | Context flag | Substance use as a cause of worsening and a driver of stopping. | Higashi 20139 |
| A change in smoking on the TAPS, on clozapine or olanzapine | Context flag, for these agents | Smoking affects the levels of both medicines. | Labels |
Guideline wording is summarized here and will be quoted exactly, with recommendation numbers, in the clinician’s report. NICE CG178 is the schizophrenia guideline. CANMAT covers the mood and anxiety components, which is where the M3 Checklist already draws on it.
Clinician material. Not a substitute for the prescribing information or clinical judgement. In an emergency, call 911; for a person in crisis, call or text 988.
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