Homeopathy versus Sertraline for depression

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-6y5dcb
• Date of registration: 25/06/2015
• Prospective Registration: No
• Primary sponsor: Unidade de Saúde Escola da Universidade Federal de São Carlos
• Public title: Homeopathy versus Sertraline for depression
• Scientific title: Homeopathy versus Sertraline - HOMEO-CON study: Homeopathy on the continuation phase of depression treatment
• Date of first enrolment: 05/08/2014
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-6y5dcb
• Study type: Intervention
• Study design: Randomized, controlled, double blind, parallel group, two-armed,treatment study.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Ubiratan Cardinalli Adler
• Affiliation: Unidade de Saúde Escola da Universidade Federal de São Carlos

• Name: Ubiratan Cardinalli Adler
• Affiliation: Unidade de Saúde Escola da Universidade Federal de São Carlos

Key inclusion & exclusion criteria

Inclusion criteria: Subjects should meet the criteria for a depressive episode (single or recurrent) following a Structured Clinical Interview,SCID; capacity and willingness to give informed consent and to comply with study procedures will also be required.

Exclusion criteria: Dysthymia; psychotic, chronic or double depression; intolerance to sertraline or a negative previous experience with the drug; bipolar disorder; schizophrenia or other psychotic disorders; substance dependence (except tobacco); bulimia or anorexia, clinical significant chronic disease that could hinder study visits or depression evaluation; suicide attempt up to 12 months before screening; treatment with antidepressants or mood stabilizers 4 weeks prior to the screening; homeopathic treatment 8 weeks prior to study entry; psychotherapy, meditation or acupuncture during the study; participation in a previous clinical trial 3 months prior to screening; concomitant pregnancy or breastfeeding; epilepsy; concomitant use of anticoagulants; patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical trial and for not complying with the necessary study procedures.

Age minimum:
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

F32.1

F32.0

Depressive episode

F32.2

F32.9

Intervention(s)

D02.092.705.800

Experimental group: 110 patients with a depressive episode diagnosis will receive an individualized homeopathic medicine in fifty-millesimal potencies (LM or Q potencies)

Control group: 110 patients with a depressive episode diagnosis will receive Sertraline, 50 - 150 mg/day, according to therapeutic response.

Patients will be randomly assigned to experimental or control group.

Each patient will be double blindly treated during 24 weeks.

Drug

E02.190.388

Primary Outcome(s)

Mean score on the Montgomery & Åsberg – (MADRS) after twelve weeks

Secondary Outcome(s)

MADRS mean score (with the exception of the primary endpoint); response and remission rates, quality of life (SF-12), at weeks 2, 4, 8, 16, 20, and 24; adverse events and dropouts during the whole trial.

Source(s) of Monetary Support

Unidade de Saúde Escola da Universidade Federal de São Carlos

Secondary Sponsor(s)

Unidade de Saúde Escola da Universidade Federal de São Carlos