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NCT03655730: MLADO
Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion
NA trial testing weekly psychotherapeutic individual sessions in Depressive Symptoms in 159 participants. Completed in 30 April 2021.
31 March 2021
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 159 |
| Start date | 3 December 2018 |
| Primary completion | 31 March 2021 |
| Estimated completion | 30 April 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- weekly psychotherapeutic individual sessions
- Usual care
Conditions studied
- Depressive Symptoms — all drugs for Depressive Symptoms →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 16 to 25, any sex, with Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries. Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt. To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS). Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level. The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6. The study also aims comparing in the 2 randomised groups * ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months * Number of suicidal attempts and self-harm attempts at 6 and 12 months * Number of drop-out at 6 and 12 months * Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months * Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months. * Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months
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 NCT03655730
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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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 NCT03655730 (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 Assistance Publique - Hôpitaux de Paris
- Last refreshed: 28 June 2021
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/NCT03655730.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing