An interventional study of Physical activity promotion + TAU and Control in Major Depressive Disorder, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
Among 53 studies in Depressive Disorder, Major with a site in Brazil — 9 open to participants now, 12 under way, 5 of them phase 3. Depressive Disorder, Major · Brazil.
Among the 53 studies in Depressive Disorder, Major with a site in Brazil, this one is the 24th largest by planned enrollment of the 50 interventional ones that give a count, is one of 2 that started in 2016, is one of 15 with no phase, and was the 20th registered.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
Browse Depressive Disorder, Major studies →9 of the 53 studies in Depressive Disorder, Major with a site in Brazil are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Brazil, United States, Australia and 12 more countries
Universidade Federal do Rio Grande do Norte · Sites in Brazil
Universidade do Sul de Santa Catarina · Sites in Brazil
Janssen Research & Development, LLC · Sites in Brazil, United States, Argentina and 4 more countries
Eli Lilly and Company · Sites in Brazil, United States, Australia and 12 more countries
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 410 Depressive Disorder, Major studies recruiting now, 92 (22%) set no upper age limit and 292 (71%) stop at 75 or younger; 54 take children under 18; 98 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 14 · Phase 3 23 · Phase 4 2
First in 2005; this study’s year is marked. 2 started in 2016.
This study's planned enrollment of 130 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 120 across the 50 interventional studies, 120 across the 3 observational. Of the 31 that completed or were terminated, 12 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 53 have an industry lead sponsor. The 10 most frequent:
Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Hospital de Clinicas de Porto Alegre has 5 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
3 of the studies in Depressive Disorder, Major with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06559306Phase 3Janssen Research & Development, LLCPhase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms | 2026-12-30 |
| NCT07696871Universidade do Sul de Santa CatarinaCannabidiol Oil for Treatment-Resistant Major Depression | 2026-12-31 |
| NCT07562191Universidade Federal do Rio Grande do NorteInhaled DMT for Major Depressive Disorder | 2027-02-01 |
Among the 53 studies in Depressive Disorder, Major with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Randomized clinical trial that aims to increase physical activity levels in people with depression and to evaluate if the increase on PA levels has impact on clinical and biological measures.
The contacts will be made by face-to-face interviews and telephone calls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physical activity promotion based on: * Pedometers use; * Weekly contact (telephone or face-to-face); * Contact based on a self-determination theory. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.
Behavioral: Physical activity promotion + TAU
Weekly calls with general health content. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.
Behavioral: Control
Pedometer: Each patient will receive a pedometer with increasing weekly aims on number of steps during the trial. The number of steps to be achieved starts on 4.000 and increases progressively until the end of the trial. Behavioral strategy based on STD theory, and the assessment of barriers and facilitators of each patient. All patients were receiving treatment as usual
Weekly call on general health aspects + treatment as usual
Depressive symptoms (blinded assessment)
Hamilton scale for depressive symptoms assessed by a blinded psychiatrist. Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher scores means higher depressive symptoms. The cutoffs are the following: following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24). The maximum score is 52.
Time frame: At the end of the intervention (6 months)
Physical activity - self-report
IPAQ
Time frame: At the end of the intervention (6 months)
Physical activity levels - objective measure
pedometer (only for intervention group)
Time frame: At the end of the intervention (6 months)
Quality of life
WHOQOL-BREF
Time frame: At the end of the intervention (6 months)
Depressive symptoms (self-reported)
Beck depressive inventory
Time frame: At the end of the intervention (6 months)
Melancholia
assessed using the CORE instrument
Time frame: At the end of the intervention (6 months)
Weight
Weight in kilograms
Time frame: At the end of the intervention (6 months)
Plan to share: Undecided
The record gives a start of Mar 2016, a primary completion of Dec 2018 and a completion of May 2019. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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