DepressiondepressionNCT01571973
Evaluation of Pharmaceutical Care in Depressed Outpatients
A study testing pharmacotherapeutic follow-up in people with Depression, run by Federal University of São Paulo.
Trial summary
The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- pharmacotherapeutic follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between 18 and 65 years, with diagnostic hypothesis of depression at the beginning of treatment or change in treatment unless 2 months (dosage or substance)
Who cannot join
- record of dependence on psychoactive substances, diagnosed schizophrenia,
- low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments
About this study
Official title: EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC
The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.
- Conditions
- Depression
- Being tested
- pharmacotherapeutic follow-up
- Keywords
- pharmaceutical care, depression, compliance, pharmacist's intervention, Dáder
- Medical subject headings
- Depression, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacotherapeutic follow-upProcedure or surgery
health education adjustment of dose improve compliance replacement of medication
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | outpatients receiving usual care |
| intervention group | Experimental | outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months Receives: Procedure: pharmacotherapeutic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression level
evaluation depression level by Beck scale
Measured: six months
Secondary outcomes (2)
anxiety level
evaluation anxiety level by Beck scale.
Measured: 6 months
compliance
evaluation antidepressive treatment compliance by Morisky scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Regina Noto, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571973
- Sponsor's protocol ID
- SPPsicobio1Lu
- Acronym
- depression
- Status last verified
- Jun 2011
- First submitted
- 3 Apr 2012
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC
- ClinicalTrials.gov ID
- NCT01571973
- Acronym / sponsor ID
- depression / SPPsicobio1Lu
- Conditions
- Depression
- Keywords
- pharmaceutical care, depression, compliance, pharmacist's intervention, Dáder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –outpatients receiving usual care |
| intervention group | Experimental | Procedure: pharmacotherapeutic follow-upoutpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women between 18 and 65 years, with diagnostic hypothesis of depression at the beginning of treatment or change in treatment unless 2 months (dosage or substance)
Key exclusion criteria (2 listed)
- record of dependence on psychoactive substances, diagnosed schizophrenia,
- low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacotherapeutic follow-uphealth education adjustment of dose improve compliance replacement of medication | Procedure or surgery | intervention group |
Primary outcome
depression level
Time frame: six months
evaluation depression level by Beck scale
2 secondary outcomes
anxiety level
Time frame: 6 months
compliance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacotherapeutic follow-up in people with Depression, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression level (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.