itrous Oxide (N2O) treatment of adolescents with depression (NOTAD)

Recruiting

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12616001568404
• Lead Sponsor: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Participants with a confirmed diagnosis of moderate to severe Major Depressive Disorder (according to ICD-10 or DSM-V)
2. Participants aged between 12 and 17 years
3. Intention to start fluoxetine as treatment in Phase B

Exclusion Criteria

1. Active suicidal ideation or plans
2. Currently taking other psychiatric medications at study entry
3. Intellectual disability
4. Active or past diagnosis of an eating disorder
5. Current or recent abuse of alcohol
and current or recent abuse of illicit substances or dependence (recent = within the past 12
months).
6.Pregnancy in female participants
7. Chronic medical or neurological disorder
8. History of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive compulsive disorder, or other Axis II diagnosis
9. Presence of acute medical illness that
could interfere with study participation, including (but not limited to) significant pulmonary
disease.
10. Active psychotic symptoms
11. Previous administration of NMDA receptor
antagonists (e.g., N2O or ketamine) during the preceding 3 months.
12. Ongoing or past treatment with electroconvulsive therapy
13. Contraindications against the use of N2O (e.g.
pneumothorax)
14. Contraindications against the use of fluoxetine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mood, assessed by the Child Depression Rating Scale - Revised (CDRS), the Beck Depression Inventory (BDI) and the Hamilton Depression Rating Scale (HDRS).[2 hours post administration of nitrous oxide or placebo]

Secondary Outcome Measures

Name	Time	Method
Mood, assessed by the Child Depression Rating Scale - Revised (CDRS), the Beck Depression Inventory (BDI) and the Hamilton Depression Rating Scale (HDRS).[24 hours after administration of nitrous oxide];Mood, assessed by the Child Depression Rating Scale - Revised (CDRS), the Beck Depression Inventory (BDI) and the Hamilton Depression Rating Scale (HDRS).[Mood will be measured on a weekly basis after the initiation of Phase B (i.e., commencement of fluoxetine treatment) for the 12 weeks of fluoxetine administration.];Mood and behaviour, assessed by the Child Behaviour Checklist (CBCL)[Measures will be conducted during Week 6 and Week 12 of follow up (Phase B).]