DepressionPhase 3NCT01043367
Deprexil in Subjects With Signs and Symptoms of Depression
A Phase 3 study testing Deprexil in people with Depression, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Depression
- What is being tested?
- Deprexil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCuba
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 3
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.
- Signed informed consent
Who cannot join
- Severe symptoms and signs of depression or Suicide proneness.
- Pregnancy or breastfeeding
- Receiving other experimental drug
- Use of anti-depressive medication within 15 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.
The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.
- Conditions
- Depression
- Being tested
- Deprexil, Placebo
- Keywords
- Depression, Dietary supplement, Deprexil
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeprexilDietary supplement
One 600 mg Deprexil tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.
PlaceboDietary supplement
One Placebo tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Deprexil Receives: Dietary Supplement: Deprexil |
| B | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capabilities at week 24 (end of the treatment)
Measured: 24 weeks
Social capabilities at week 24 (end of the treatment)
Measured: 24 weeks
Psycho-affective capabilities at week 24 (end of the treatment)
Measured: 24 weeks
Behavioral capabilities at week 24 (end of the treatment)
Measured: 24 weeks
Secondary outcomes (4)
Tolerability to Deprexil at week 24 (end of the treatment)
Measured: 24 weeks
Symptoms of depression at week 24 (end of the treatment)
Measured: 24 weeks
Signs of depression at week 24 (end of the treatment)
Measured: 24 weeks
Clinical symptoms of baseline disease at 24 weeks (end of the treatment)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maria de la Concepción Valdivia Alarcón, MD, Principal investigator, "Heroes del Moncada" Polyclinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043367
- Sponsor's protocol ID
- CAT-0908-CU
- Status last verified
- Mar 2011
- First submitted
- 5 Jan 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.
- ClinicalTrials.gov ID
- NCT01043367
- Acronym / sponsor ID
- CAT-0908-CU
- Conditions
- Depression
- Keywords
- Depression, Dietary supplement, Deprexil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Jan 2010 (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 purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: DeprexilDeprexil |
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.
- Signed informed consent
Key exclusion criteria (4 listed)
- Severe symptoms and signs of depression or Suicide proneness.
- Pregnancy or breastfeeding
- Receiving other experimental drug
- Use of anti-depressive medication within 15 days
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 |
|---|---|---|
| DeprexilOne 600 mg Deprexil tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week. | Dietary supplement | A |
| PlaceboOne Placebo tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week. | Dietary supplement | B |
Primary outcome
Functional capabilities at week 24 (end of the treatment)
Time frame: 24 weeks
Social capabilities at week 24 (end of the treatment)
Time frame: 24 weeks
Psycho-affective capabilities at week 24 (end of the treatment)
Time frame: 24 weeks
Behavioral capabilities at week 24 (end of the treatment)
Time frame: 24 weeks
4 secondary outcomes
Tolerability to Deprexil at week 24 (end of the treatment)
Time frame: 24 weeks
Symptoms of depression at week 24 (end of the treatment)
Time frame: 24 weeks
Signs of depression at week 24 (end of the treatment)
Time frame: 24 weeks
Clinical symptoms of baseline disease at 24 weeks (end of the treatment)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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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.
Maria de la Concepción Valdivia Alarcón, MD principal investigator
"Heroes del Moncada" Polyclinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deprexil in people with Depression, run by Catalysis SL at 1 site in Cuba.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional capabilities at week 24 (end of the treatment) (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 8 Mar 2011.