Psychoeducational Group for Depression

NARecruitingINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

December 1, 2026

Conditions
Major Depressive Disorder (MDD
Interventions
BEHAVIORAL

PEG-D program

PEG-D will be carried out in person, open format, for six consecutive weeks lasting 90 minutes each. An approximate group of 6 to 10 participants will be led by a team of experienced psychologists and psychiatrists. Each group will have a main therapist and a co-therapist to ensure effective support and guidance for participants. Before the start of the group, participants received a booklet containing the content of the sessions.

DRUG

TAU

The treatment will start with Sertraline (SSRI) - doses of 50 mg and adjusting as necessary according to the patient\'s profile. After 8 weeks, if the patient experiences remission, they will continue on monotherapy with Sertraline. In case of relapse Bupropion, Quetiapine, Lithium or Aripiprazole might be add-on. In this case, add-on medications will be determined according to the patient profile, by the clinician. If there is a response above 25% of the symptoms, but without remission, the patient will proceed to augmentation with the aforementioned medications and if there is no improvement of at least 25%, the patient will be considered drop-out. Associations with Lorazepam if necessary will be allowed in any phase of the study.

Trial Locations (1)

05403903

RECRUITING

Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo, São Paulo

All Listed Sponsors
lead

Ricardo Alberto Moreno, M.D., Ph.D.

OTHER