Major Depressive DisorderPhase 1Srt+ktpMDDNCT03514810
Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
A Phase 1 study testing Combined Sertraline & Ketoprofen and Interleukins in MDD after treatment in people with Major Depressive Disorder, run by Kufa University.
Trial summary
Among the major depressive disorder (MDD) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any medicine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Combined Sertraline & Ketoprofen and Interleukins in MDD after treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2017to 31 Dec 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients were diagnosed by psychiatrists in accordance ICD10 as having major depressive disorder.
- The patients had no existing systemic disease that may affect the parameters to be diagnosed.
- Patients with negative serum C-reactive protein (CRP<6 mg/L).
Who cannot join
- Patients with any systemic disease particularly diabetes, liver disease, and renal disease
- Patients with positive CRP
- Patients who taking any other drugs
About this study
Among the major depressive disorder (MDD) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any medicine.
Read the detailed description
The research is a prospective, 2-month, double-blind study of parallel groups of patients with MDD with or without ketoprofen administration in addition to sertralin.
- Patients: A total of 140 patients with MDD (78 male and 62 female; aged 18-65 years) participated in the study. Two samples were obtained at the beginning and 2 months after treatment from 34 patients that were followed up for two months after treatment. The samples were collected from "The Psychiatry Unit" at Al-Hakeem General Hospital in Najaf Governorate-Iraq from November 2016 to August 2017. Patient samples were also obtained from a private psychiatric clinic that was run by an assistant professor in psychiatric medicine. The patients were diagnosed by psychiatrists in accordance with a semi-structured psychiatric interview schedule for MDD diagnosis based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems. The full medical histories of the patients were evaluated such that any existing systemic disease that may affect the parameters to be diagnosed, particularly diabetes, liver disease, and renal disease, were excluded. Patients with histories of these diseases were excluded from the study. Serum C-reactive protein (CRP) was negative in all of the samples (CRP<6 mg/L). This test was conducted to exclude the presence of any overt infection or inflammation that may elevate acute-phase-reactant proteins, especially CRP. The protocol was approved by the IRB of the University of Kufa. The patients or their close first-degree relatives provided informed consent in accordance with the procedures outlined by the current IRB. Among the patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD.
- Controls: As part of the control group, 40 apparently healthy subjects (22 males and 18 females) were selected. Their sex and age were matched with those of the patients. These subjects were apparently free from psychiatric and somatic diseases.
- Conditions
- Major Depressive Disorder
- Being tested
- Combined Sertraline & Ketoprofen, Interleukins in MDD after treatment
- Keywords
- Major depressive disorder, sertraline, ketoprofen
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Sertraline & KetoprofenCombination product
Also called Zoloft & Ketoprofen
The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline \& Ketoprofen) daily.
Interleukins in MDD after treatmentOther
Also called Effect Ketoprofen & Sertraline on MDD
Some interleukine levels were estimated in the first group of patients (administered sertralin,50mg+ketoprofen,100mg) and compared with their level in the second group (administered sertralin (50mg)+placebo).
| Study group | Role | What they receive |
|---|---|---|
| Sertralin & Ketoprofen in MDD | Placebo comparator | To compare the median of Beck Depression Inventory-II (BDI-II) score of MDD patients after treatment with sertralin (50mg) daily+placebo and after treatment with combination of (sertralin \& ketoprofen) for two months. Receives: Combination Product: Combined Sertraline & Ketoprofen; Other: Interleukins in MDD after treatment |
| Interleukins in MDD after treatment | Experimental | Some Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily. Receives: Combination Product: Combined Sertraline & Ketoprofen; Other: Interleukins in MDD after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Beck Depression Inventory-II Score
BDI-II is a 21-item self-report scale measuring current depressive symptoms. The standardized cutoffs used differ from the original:
- 0-13: minimal depression
- 14-19: mild depression
- 20-28: moderate depression
- 29-63: severe depression. Reduction in the Beck Depression Inventory-II Score by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Measured: 12 months
Secondary outcomes (2)
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder.
All these cytokines were measured using ng/ml unit.
Measured: 12 months
Body mass index (BMI)
Body mass index (BMI) is a measure for obesity and low weight measure. It is chosen because the MDD patients have a change in appetite and monitoring the weight is importany indication of normal appetite and cure. BMI Categories:
Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start10 Jan 2017
- Primary completion10 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Kadhem Al-Hakeim, Kufa University
- Investigators
- Arafat H Al-dujaili, PhD, Principal investigator, Head of Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514810
- Sponsor's protocol ID
- KufaU
- Other IDs
- Arafataldujaili
- Acronym
- Srt+ktpMDD
- Status last verified
- May 2018
- First submitted
- 13 Apr 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Direct contact on my e-mail:headm2010@yahoo.com
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03514810
- Acronym / sponsor ID
- Srt+ktpMDD / KufaU
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, sertraline, ketoprofen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 May 2018 (actual)
- 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.
Among the major depressive disorder (MDD) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any medicine.
Detailed description
The research is a prospective, 2-month, double-blind study of parallel groups of patients with MDD with or without ketoprofen administration in addition to sertralin.
- Patients: A total of 140 patients with MDD (78 male and 62 female; aged 18-65 years) participated in the study. Two samples were obtained at the beginning and 2 months after treatment from 34 patients that were followed up for two months after treatment. The samples were collected from "The Psychiatry Unit" at Al-Hakeem General Hospital in Najaf Governorate-Iraq from November 2016 to August 2017. Patient samples were also obtained from a private psychiatric clinic that was run by an assistant professor in psychiatric medicine. The patients were diagnosed by psychiatrists in accordance with a semi-structured psychiatric interview schedule for MDD diagnosis based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems. The full medical histories of the patients were evaluated such that any existing systemic disease that may affect the parameters to be diagnosed, particularly diabetes, liver disease, and renal disease, were excluded. Patients with histories of these diseases were excluded from the study. Serum C-reactive protein (CRP) was negative in all of the samples (CRP<6 mg/L). This test was conducted to exclude the presence of any overt infection or inflammation that may elevate acute-phase-reactant proteins, especially CRP. The protocol was approved by the IRB of the University of Kufa. The patients or their close first-degree relatives provided informed consent in accordance with the procedures outlined by the current IRB. Among the patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD.
- Controls: As part of the control group, 40 apparently healthy subjects (22 males and 18 females) were selected. Their sex and age were matched with those of the patients. These subjects were apparently free from psychiatric and somatic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertralin & Ketoprofen in MDD | Placebo comparator | Combination Product: Combined Sertraline & Ketoprofen, Other: Interleukins in MDD after treatmentTo compare the median of Beck Depression Inventory-II (BDI-II) score of MDD patients after treatment with sertralin (50mg) daily+placebo and after treatment with combination of (sertralin \& ketoprofen) for two months. |
| Interleukins in MDD after treatment | Experimental | Combination Product: Combined Sertraline & Ketoprofen, Other: Interleukins in MDD after treatmentSome Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients were diagnosed by psychiatrists in accordance ICD10 as having major depressive disorder.
- The patients had no existing systemic disease that may affect the parameters to be diagnosed.
- Patients with negative serum C-reactive protein (CRP<6 mg/L).
Key exclusion criteria (3 listed)
- Patients with any systemic disease particularly diabetes, liver disease, and renal disease
- Patients with positive CRP
- Patients who taking any other drugs
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 |
|---|---|---|
| Combined Sertraline & KetoprofenAlso: Zoloft & KetoprofenThe first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline \& Ketoprofen) daily. | Combination product | Interleukins in MDD after treatment, Sertralin & Ketoprofen in MDD |
| Interleukins in MDD after treatmentAlso: Effect Ketoprofen & Sertraline on MDDSome interleukine levels were estimated in the first group of patients (administered sertralin,50mg+ketoprofen,100mg) and compared with their level in the second group (administered sertralin (50mg)+placebo). | Other | Interleukins in MDD after treatment, Sertralin & Ketoprofen in MDD |
Primary outcome
Reduction in the Beck Depression Inventory-II Score
Time frame: 12 months
BDI-II is a 21-item self-report scale measuring current depressive symptoms. The standardized cutoffs used differ from the original: * 0-13: minimal depression * 14-19: mild depression * 20-28: moderate depression * 29-63: severe depression. Reduction in the Beck Depression Inventory-II Score by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
2 secondary outcomes
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels
Time frame: 12 months
Body mass index (BMI)
Time frame: 2 months
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 3 May 2018.
- Individual participant dataSharing planned: No. Direct contact on my e-mail:headm2010@yahoo.com
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Arafat H Al-dujaili, PhD principal investigator
Head of Department of Psychiatry
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combined Sertraline & Ketoprofen and Interleukins in MDD after treatment in people with Major Depressive Disorder, run by Kufa University.
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 3 inclusion and 3 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 3 May 2018. 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. 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 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.
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?
Reduction in the Beck Depression Inventory-II Score (time frame: 12 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 3 May 2018.