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NCT05554289
Efficacy, Safety, and Acceptability of Internet-based Cognitive Behavioral Therapy
NA trial testing Depression Auxiliary Intervention Treatment Software (WL-iCBT) in Depression in 315 participants. Completed in 25 October 2024.
15 March 2024
Quick facts
| Lead sponsor | Adai Technology (Beijing) Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 315 |
| Start date | 21 April 2023 |
| Primary completion | 15 March 2024 |
| Estimated completion | 25 October 2024 |
| Sites | 11 locations across China |
Drugs / interventions tested
- Depression Auxiliary Intervention Treatment Software (WL-iCBT)
- Placebo Control Software (WL-iHE)
Conditions studied
- Depression — all drugs for Depression →
Sponsor
Adai Technology (Beijing) Co., Ltd.
Who can join
Adults 18 to 60, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, randomized, multicenter, double-blind, placebo-controlled phase III trial evaluating the efficacy and safety of WL-iCBT - a smartphone-based digital therapeutic combining cognitive behavioral therapy and attention bias modification. The study enrolls 315 participants aged 18-60 with mild-to-moderate MDD (MADRS score 18-30) across 11 clinical centers in China. Participants will be randomized to receive either active WL-iCBT or placebo software for 8 weeks, followed by a 26-week observational extension phase. Primary endpoint is change in MADRS score from baseline to Week 8. Secondary endpoints include treatment response rate, remission rate, anxiety symptoms (HAMA), functional impairment (SDS), and cognitive function (PDQ-D), and Clinical Global Impression rating scale (CGI). Safety monitoring includes AE/SAE recording and device deficiency assessment. Acceptability will be assessed by device performance evaluation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05554289
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Adai Technology (Beijing) Co., Ltd. trials
Trials by the same sponsor.
- NCT07319325 — Efficacy of Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Co · NA · completed
- NCT06778785 — Game-Based Digital Intervention for Depression in Adolescents · NA · active not recruiting
- NCT06349993 — Digital Intervention for Depression and Anxiety in Adolescents · NA · recruiting
- NCT06423443 — Digital Cognitive Behavioral Therapy for Depressive Disorders · NA · recruiting
- NCT06301555 — Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05554289 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Adai Technology (Beijing) Co., Ltd.
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05554289.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing