Evaluation of biological markers (psychological and physiological) after therapy to reeducate thinking and behavior in university students with Major Depressive Disorder.

Evaluation of psychophysiological biomarkers after Cognitive-Behavioral Therapy in university students with Major Depressive Disorder.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-3npbf8

Enrollment

Unknown

Registered

2018-08-31

Start date

2018-03-05

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other depressive episods

Interventions

The study will be performed at the Federal University of Rio Grande do Norte (UFRN), Natal-RN

public of 108 volunteers, all students of UFRN, of both sexes, with aged between 18 and 35 years. Control group: 36 healthy volunteers, who will not receive any treatment

psychotherapy or drug intervention. Experimental group: 72 patients with Major Depressive Disorder in mild to moderate degree. The 72 participants in the experimental group will be divided into two

Drug

Behavioural

F04.754.864.581

Eligibility

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer (control) - No diagnostic or history of psychiatric disorders; age from 18 to 35 years and be a student of UFRN. TDM patient - presence of current depressive episode, with mild or moderate grade; age from 18 to 35 years and be a student of UFRN.

Exclusion criteria

Exclusion criteria: Healthy volunteer - Current diagnosis of clinical disease based on anamnesis and/or laboratory tests; present suicidal risk; diagnosis of Bipolar disorder, types I or II; show specific phobic symptoms for injection-blood-injury; presence or history of psychotic symptoms, mania or hypomania, induced or not by antidepressants or substance use; abuse or dependence on alcohol and other drugs; pregnancy. TDM patient - present severe levels of depression (according to the Hamilton Depression Rating Scale (HAM-D) and / or the Montgomery and Asberg Depression Rating Scale (MADRS)); use psychiatric or neurological medications or drugs with effects on cognition, mood, and neurovegetative functions; be in treatment by psychotherapy; show diagnostic for others mental disorder in addition to major depression; present phobic specific symptoms of injection-blood-injury; pregnancy.

Design outcomes

Primary

Measure	Time frame
Validation of a panel of biomarkers for diagnosis, prognosis and follow-up of major depressive disorders (MDD); Show the efficacy of Cognitive-Behavioral Therapy in group for MDD treatment, comparing it with SSRI drug, a pharmacological antidepressant treatment.	—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Brazil

Contacts

Public ContactNicole Galvão-Coelho

Universidade Federal do Rio Grande do Norte

nicolelgalvaocoelho@gmail.com55 84 3215-3410

Outcome results

None listed

Source: REBEC (via WHO ICTRP)