{"id":"d152c5aa-d281-5dfc-8934-1deccd98d218","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dysthymia-noninferiority","predicate":"context_dependent_observation","statement":"The ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"fb83f83d-dee3-524a-8061-335b7f46026a","mechanism_event_label":"The ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.","subject":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"object":{"id":"1a21a96c-f54e-5610-ad98-248af91555c0","slug":"human-dysthymia-hamd","display_name":"Human dysthymia Hamilton depression score","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"fb83f83d-dee3-524a-8061-335b7f46026a","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dysthymia-noninferiority-event","event_type":"experimental_observation","label":"The ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.","description":"### dysthymia-noninferiority\n\nThe ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.\nThe confidence interval exceeded the prespecified margin by 0.46 points. A wider three-point margin discussed afterward does not replace the original test. Both arms improved; nonsignificant superiority does not prove equivalence.\nModel and exposure: 204 randomized; ALCAR 500 mg twice daily versus amisulpride 50 mg/day for 12 weeks.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: A double-blind, randomised, controlled clinical trial of acetyl-L-carnitine vs. amisulpride in the treatment of dysthymia. | 2006 | https://pubmed.ncbi.nlm.nih.gov/16316746/ | https://doi.org/10.1016/j.euroneuro.2005.10.005 | Access: Indexed primary abstract/metadata only; unextracted doses, figures and methods remain unknown.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"role":"tested factor","stoichiometry":null,"state_label":"ALCAR regimen","sequence_order":0,"notes":""},{"entity":{"id":"1a21a96c-f54e-5610-ad98-248af91555c0","slug":"human-dysthymia-hamd","display_name":"Human dysthymia Hamilton depression score","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"mixed","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Indexed primary abstract/metadata only; unextracted doses, figures and methods remain unknown.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_contrast","value_text":"{\"intervention\": \"ALCAR regimen\", \"comparator\": \"Amisulpride regimen\", \"endpoint\": \"The ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.\", \"effect_direction\": \"mixed\", \"combination\": \"single\", \"conditions\": []}","comparator":null,"unit":null,"notes":"Explicit extracted experimental comparison; source-derived draft.","entity":null},{"dimension":"experimental_model","value_text":"204 randomized; ALCAR 500 mg twice daily versus amisulpride 50 mg/day for 12 weeks.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"interpretation_status","value_text":"Source-derived curation with stated access limits; ungraded, not independent replication.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Acetyl-L-carnitine collection; exact intervention and molecular form govern interpretation.","comparator":null,"unit":null,"notes":"","entity":{"slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"}},{"dimension":"plain_language","value_text":"The ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"A double-blind, randomised, controlled clinical trial of acetyl-L-carnitine vs. amisulpride in the treatment of dysthymia. | https://pubmed.ncbi.nlm.nih.gov/16316746/ | https://doi.org/10.1016/j.euroneuro.2005.10.005","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference dysthymia-noninferiority; The confidence interval exceeded the prespecified margin by 0.46 points. A wider three-point margin discussed afterward does not replace the original test. Both arms improved; nonsignificant superiority does not prove equivalence.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"3516bd3b-88ca-52cb-a2ec-6a228a15107e","evidence_kind":"source_excerpt","locator":"Lines 587-593","start_line":587,"end_line":593,"excerpt":"### dysthymia-noninferiority\n\nThe ALCAR–amisulpride trial did not meet its prespecified two-point noninferiority margin.\nThe confidence interval exceeded the prespecified margin by 0.46 points. A wider three-point margin discussed afterward does not replace the original test. Both arms improved; nonsignificant superiority does not prove equivalence.\nModel and exposure: 204 randomized; ALCAR 500 mg twice daily versus amisulpride 50 mg/day for 12 weeks.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: A double-blind, randomised, controlled clinical trial of acetyl-L-carnitine vs. amisulpride in the treatment of dysthymia. | 2006 | https://pubmed.ncbi.nlm.nih.gov/16316746/ | https://doi.org/10.1016/j.euroneuro.2005.10.005 | Access: Indexed primary abstract/metadata only; unextracted doses, figures and methods remain unknown.","model_system":"204 randomized; ALCAR 500 mg twice daily versus amisulpride 50 mg/day for 12 weeks.","directness":"reported_statement","verification_status":"source_recorded","notes":"Original paraphrase in the retained reviewed reference, not a verbatim primary-paper quotation. Access level is explicit.","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"2588f904-245a-597a-8a12-65118013fb90","stable_key":"import-e3f6ce02-0bd7-5103-acc1-68503ab6751b","title":"Acetyl-L-carnitine: detailed mechanisms of action (reviewed 6 October 2026)","document_type":"imported_text","citation_label":"AI-assisted original review of primary studies and clearly identified official records. Exact primary access is stated; no independent replication is claimed.","file_path":"","sha256":"84cc82d6fbb0fd5d73c4ce779e9f88e7f0184ba2d29b18ad0f153815380f2975","revision_id":"dac7a950-dbe5-5c7a-9c70-2ea711d5c71a","review_status":"source_recorded","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}