Depression SuicidalPhase 1/2NCT01413854
Diclofenac add-on to Treatment as Usual for Suicidal Patients
A Phase 1/2 study testing sugar pill and Diclofenac in people with Depression Suicidal, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Suicidal
- What is being tested?
- sugar pill and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Aug 2011
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Depressive disorder
- Montgomery Asberg Rating Scale Score more than 20 p.
- Recent suicide attempt (Treated as inpatient due to a recent suicide attempt)
- Informed consent
- Competence to give informed consent
Who cannot join
- Pregnancy
- Breastfeeding
- Serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases
- Ongoing substance abuse
- Schizophrenia or other psychotic disorders
- Ongoing psychosis
Show all 13Show fewer
- Risk factors for cardiovascular events
- Ulcer or gastrointestinal bleeding
- Ongoing Electroconvulsive therapy
- Previous allergic reaction to NSAID, acetylsalicylic acid, sulfonamides or the diclofenac or sugar pill content
- Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Ongoing treatment with warfarin or other anticoagulants
- Ongoing treatment with ACE inhibitors or angiotensin II antagonists Ongoing treatment with drugs known to effect the immune system Ongoing treatment with rifampicin, carbamazepine or barbiturates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"
The purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.
Read the detailed description
The study will start with a feasibility study including treatment of 10 patients with diclofenac.
- Conditions
- Depression Suicidal
- Being tested
- sugar pill, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar pillDrug
Also called One tablet two times daily during four weeks
One tablet two times daily during four weeks
DiclofenacDrug
Also called 50 mg, two times daily (oral adm.) during four weeks
50 mg, two times daily (oral adm.) during four weeks
| Study group | Role | What they receive |
|---|---|---|
| diclofenac | Active comparator | Not described Receives: Drug: Diclofenac |
| sugar pill | Placebo comparator | Not described Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Assessment Scale (differences in scores before and after treatment)
Measured: four weeks of treatment
Secondary outcomes (6)
Montgomery Asberg Rating Scale (differences in scores before and after treatment)
Measured: four weeks of treatment
Barratt Impulsiveness Scale (differences in scores before and after treatment)
Measured: four weeks of treatment
Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment)
Measured: four weeks of treatment
Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)
Measured: four weeks of treatment
Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment)
Measured: four weeks of treatment
Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment)
Measured: four weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Not enough recources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression SuicidalStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Åsa Westrin, MD, Phd, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413854
- Sponsor's protocol ID
- eudraCT number 2010-021024-10
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2011
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"
- ClinicalTrials.gov ID
- NCT01413854
- Acronym / sponsor ID
- eudraCT number 2010-021024-10
- Conditions
- Depression Suicidal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough recources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Aug 2011 (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 this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.
Detailed description
The study will start with a feasibility study including treatment of 10 patients with diclofenac.
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 |
|---|---|---|
| diclofenac | Active comparator | Drug: Diclofenac |
| sugar pill | Placebo comparator | Drug: sugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Depressive disorder
- Montgomery Asberg Rating Scale Score more than 20 p.
- Recent suicide attempt (Treated as inpatient due to a recent suicide attempt)
- Informed consent
- Competence to give informed consent
Key exclusion criteria (13 listed)
- Pregnancy
- Breastfeeding
- Serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases
- Ongoing substance abuse
- Schizophrenia or other psychotic disorders
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 |
|---|---|---|
| sugar pillAlso: One tablet two times daily during four weeksOne tablet two times daily during four weeks | Drug | sugar pill |
| DiclofenacAlso: 50 mg, two times daily (oral adm.) during four weeks50 mg, two times daily (oral adm.) during four weeks | Drug | diclofenac |
Primary outcome
Suicide Assessment Scale (differences in scores before and after treatment)
Time frame: four weeks of treatment
6 secondary outcomes
Montgomery Asberg Rating Scale (differences in scores before and after treatment)
Time frame: four weeks of treatment
Barratt Impulsiveness Scale (differences in scores before and after treatment)
Time frame: four weeks of treatment
Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment)
Time frame: four weeks of treatment
Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)
Time frame: four weeks of treatment
Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment)
Time frame: four weeks of treatment
Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment)
Time frame: four weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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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.
Åsa Westrin, MD, Phd principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sugar pill and Diclofenac in people with Depression Suicidal, run by Region Skane at 1 site in Sweden.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 Jan 2019. 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 Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Suicide Assessment Scale (differences in scores before and after treatment) (time frame: four weeks of treatment). 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 10 Jan 2019.