Mental DisordersPhase 4NCT03830398
Comparison of Drugs on Headache Treatment After ECT Treatment
A Phase 4 study testing Paracetamol and Deksketoprofen trometamol in people with Mental Disorders, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Paracetamol and Deksketoprofen trometamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2018to Jun 2019
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who were admitted for ECT and gave informed written consent were included in the study.
Who cannot join
- Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mustafa Kemal University Medicine Faculty Anesthesiology Department
Hatay, 31000
Onur Koyuncu, Assist. Prof, 5337744757, onurko@yahoo.com
Onur Koyuncu, Assoc.Prof
About this study
Official title: Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment
Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT.
Read the detailed description
Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems. The most common seen adverse effect is headache with approximately 60% incidence. The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol. The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.
- Conditions
- Mental Disorders
- Being tested
- Paracetamol, Deksketoprofen trometamol, Placebo
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Parol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Deksketoprofen trometamolDrug
Also called Sertofen
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
PlaceboDrug
Also called Serum Physiologic
The investigators apply placebo during a week in preoperative room 45 min before ECT
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Parol group: intravenous infusion in 30 min Generic name: Parol Dosage form: intravenous Dosage: 1 gr Frequency: preop one dose only Duration: For one week Receives: Drug: Paracetamol |
| Deksketoprofen trometamol | Active comparator | Sertofen group: intravenous infusion in 30 min Generic name: Sertofen Dosage form: intravenous Dosage: 50 mg Frequency: preop one dose only Duration: For one week Receives: Drug: Deksketoprofen trometamol |
| Placebo | Placebo comparator | Placebo group: intravenous infusion in 30 min Generic name: Serum physiologic Dosage form: intravenous Dosage: 100 ml Frequency: preop one dose only Duration: For one week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache (Visual Analogue Scale 0-10)
Headache (VAS) change is being assessed in three different time frames after ECT
Measured: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Secondary outcomes (2)
Additive analgesic-antiemetic consumption
If VAS ≥ 4, then diclofenac sodium im is given- If nausea-vomiting occurs, ondansetrone 4mg iv is given.The numbers of given drugs will be recorded in each interval.
Measured: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Adverse effects (Nausea-Vomiting, bradycardia, hypotension)
Number of adverse efffects will be recorded in each interval.
Measured: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start20 Nov 2018
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Each drug for one week
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koyuncu, Mustafa Kemal University
- Investigators
- Onur Koyuncu, Asc.Prof, Principal investigator, Mustafa Kemal Univ.Sedat Hakimoglu, Asc.Prof, Study chair, Mustafa Kemal Univ.Senem Urfalı, Ast.Prof, Study director, Mustafa Kemal Univ.Sumeyra Yesil, Resident, Principal investigator, Mustafa Kemal Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830398
- Sponsor's protocol ID
- 2018/171
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Isuru A, Rodrigo A, Wijesinghe C, Ediriweera D, Premadasa S, Wijesekara C, Kuruppuarachchi L. A randomized, double-blind, placebo-controlled trial on the role of preemptive analgesia with acetaminophen [paracetamol] in reducing headache following electroconvulsive therapy [ECT]. BMC Psychiatry. 2017 Jul 28;17(1):275. doi: 10.1186/s12888-017-1444-6.
PubMed 28754173
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment
- ClinicalTrials.gov ID
- NCT03830398
- Acronym / sponsor ID
- 2018/171
- Conditions
- Mental Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 Feb 2019 (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.
Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT.
Detailed description
Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems. The most common seen adverse effect is headache with approximately 60% incidence. The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol. The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Each drug for one week
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: ParacetamolParol group: intravenous infusion in 30 min Generic name: Parol Dosage form: intravenous Dosage: 1 gr Frequency: preop one dose only Duration: For one week |
| Deksketoprofen trometamol | Active comparator | Drug: Deksketoprofen trometamolSertofen group: intravenous infusion in 30 min Generic name: Sertofen Dosage form: intravenous Dosage: 50 mg Frequency: preop one dose only Duration: For one week |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group: intravenous infusion in 30 min Generic name: Serum physiologic Dosage form: intravenous Dosage: 100 ml Frequency: preop one dose only Duration: For one week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who were admitted for ECT and gave informed written consent were included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.
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 |
|---|---|---|
| ParacetamolAlso: ParolThe investigators apply paracetamol during a week in preoperative room 45 min before ECT | Drug | Paracetamol |
| Deksketoprofen trometamolAlso: SertofenThe investigators apply paracetamol during a week in preoperative room 45 min before ECT | Drug | Deksketoprofen trometamol |
| PlaceboAlso: Serum PhysiologicThe investigators apply placebo during a week in preoperative room 45 min before ECT | Drug | Placebo |
Primary outcome
Headache (Visual Analogue Scale 0-10)
Time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Headache (VAS) change is being assessed in three different time frames after ECT
2 secondary outcomes
Additive analgesic-antiemetic consumption
Time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Adverse effects (Nausea-Vomiting, bradycardia, hypotension)
Time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Results publication: PubMed 28754173Isuru A, Rodrigo A, Wijesinghe C, Ediriweera D, Premadasa S, Wijesekara C, Kuruppuarachchi L. A randomized, double-blind, placebo-controlled trial on the role of preemptive analgesia with acetaminophen [paracetamol] in reducing headache following electroconvulsive therapy [ECT]. BMC Psychiatry. 2017 Jul 28;17(1):275. doi: 10.1186/s12888-017-1444-6.
- Individual participant dataSharing planned: Undecided
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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.
Onur Koyuncu, Asc.Prof principal investigator
Mustafa Kemal Univ.
Sedat Hakimoglu, Asc.Prof study chair
Mustafa Kemal Univ.
Senem Urfalı, Ast.Prof study director
Mustafa Kemal Univ.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Deksketoprofen trometamol in people with Mental Disorders, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 1 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 Feb 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Cagla Buket Akkurt, Prof (+905053783204, caglabuket@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache (Visual Analogue Scale 0-10) (time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830398, which also lists 1 linked publication.
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 Feb 2019.