Major depressive disorder MedDRA version: 18.0 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873
Conditions
Interventions
Product Name: Neuropeptide Y (NPY) Acetate
Pharmaceutical Form: Powder and solvent for nasal drops, solution
INN or Proposed INN: Neuropeptide Y
Other descriptive name: Neuropeptide Y Acetate
Concentr
Sponsors
Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients, age =25 2.Signed informed consent 3.Patients diagnosed with recurrent major depression according to DSM-5 confirmed with SCID, and a history of at least one previous episode, currently in treatment with a minimum MADRS-M score of 28 4.Female patient of child bearing age must be willing to ensure that they use effective contraception during the study (e.g. combination of barrier method and spermicide; sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomised partner) 5.Patient has acceptable laboratory, vital signs and ECG results (as judged by the investigator) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Any changes in antidepressant treatment within 3 weeks before study inclusion 2.Current manic or mixed affective episode or schizoaffective disease as well as patients with suicide risk 3. Nasal pathology (e.g. chronic rhinitis) that can affect the uptake of NPY 4.Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 5.Current substance abuse or dependence 6.Female patient who is pregnant, lactating or planning pregnancy during the course of the trial 7.Positive alcohol breath test 8.Participation in another study with an investigational drug within 3 months before study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: study if NPY decreases symptoms of depression;Secondary Objective: study any changes in QIDS-SR16;Primary end point(s): Reduction in MADRS-M scores from Screening to Visit 6 (Day 11) ;Timepoint(s) of evaluation of this end point: From Screening to Visit 6 (Day 11) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): reduction in MADRS-M scores from Screening to Visit 5 (Day 4) reduction in MADRS-M scores from Screening to Visit 7 (Day 18) reduction in QIDS-SR16 from Screening to Visit 5 (Day 4) reduction in QIDS-SR16 from Screening to Visit 6 (Day 11) reduction in QIDS-SR16 from Screening to Visit 7 (Day 18) ;Timepoint(s) of evaluation of this end point: reduction in MADRS-M scores from Screening to Visit 5 (Day 4) reduction in MADRS-M scores from Screening to Visit 7 (Day 18) reduction in QIDS-SR16 from Screening to Visit 5 (Day 4) reduction in QIDS-SR16 from Screening to Visit 6 (Day 11) reduction in QIDS-SR16 from Screening to Visit 7 (Day 18) | — |
Countries
Sweden
Contacts
Public ContactMD, PhD, Senior Professor
Karolinska University Hospital, Huddinge
Outcome results
None listed