{
  "topic": {
    "stem": "ZURANOLONE_PPD_MDD_REVIEW",
    "name": "Zuranolone in MDD and PPD",
    "ncts": [
      "NCT04442737",
      "NCT04476030"
    ],
    "drug_patterns": [
      "zuranolone",
      "sage-217"
    ],
    "condition_patterns": [
      "depress"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": false,
        "C_condition_in_aact": false,
        "D_pmid_topic_match": false,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04442737",
        "aact_title": "A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain",
        "aact_acronym": "DEFINE",
        "start_date": "2020-07-01",
        "primary_completion_date": "2023-08-07",
        "aact_intvs": [
          "D/C/F/TAF FDC",
          "TAF/FTC FDC",
          "INI Based Regimen"
        ],
        "aact_conditions": [
          "hiv-1"
        ],
        "pmid": "39230668",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1093/cid/ciae449",
        "aact_per_arm_counts": {
          "BG000": 53,
          "BG001": 50
        },
        "aact_primary_outcome_measure": "Percent Change From Baseline in Body Weight at Week 24",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "10.9"
          ],
          [
            "OG001",
            "4.1"
          ],
          [
            "OG003",
            "30.0"
          ],
          [
            "OG000",
            "44.0"
          ],
          [
            "OG002",
            "0.0"
          ],
          [
            "OG002",
            "47.6"
          ],
          [
            "OG000",
            "59.2"
          ],
          [
            "OG002",
            "45.7"
          ],
          [
            "OG000",
            "56.8"
          ],
          [
            "OG001",
            "52.3"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04476030",
        "aact_title": "A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder",
        "aact_acronym": "",
        "start_date": "2020-11-09",
        "primary_completion_date": "2021-10-25",
        "aact_intvs": [
          "SAGE-217",
          "Matching Placebo",
          "Sertraline",
          "Escitalopram",
          "Citalopram",
          "Duloxetine",
          "Desvenlafaxine"
        ],
        "aact_conditions": [
          "depressive disorder, major"
        ],
        "pmid": "37875578",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1038/s41386-023-01751-9",
        "aact_per_arm_counts": {
          "BG000": 218,
          "BG001": 212
        },
        "aact_primary_outcome_measure": "Change From Baseline in the HAMD-17 Total Score at Day 3",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "49.2"
          ],
          [
            "OG001",
            "53.4"
          ],
          [
            "OG000",
            "65.3"
          ],
          [
            "OG001",
            "59.9"
          ],
          [
            "OG000",
            "21.8"
          ],
          [
            "OG001",
            "29.1"
          ],
          [
            "OG000",
            "39.2"
          ],
          [
            "OG001",
            "37.9"
          ],
          [
            "OG000",
            "12.9"
          ],
          [
            "OG001",
            "22.9"
          ]
        ]
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 2,
    "E_two_arms": 2,
    "F_primary_outcome_known": 2,
    "B_drug_in_intvs": 1,
    "C_condition_in_aact": 1,
    "D_pmid_topic_match": 1
  },
  "n_total": 2,
  "n_pass_all": 1,
  "pass_rate": 0.5,
  "verdict": "VIABLE"
}