DepressionPhase 1NCT01311570
Study Assessing the Safety and Therapeutic Effect of Buprenorphine in MDD Patients
A Phase 1 study testing Buprenorphine in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population. The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Depression
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Feb 2013
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients and inpatients
- Men and women 18-68 years of age.
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
- Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
- The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
- If currently taking Benzodiazepines, the patient must be clinically appropriate to discontinue treatment with those agents, and able to tolerate no benzodiazepines during the study period.
- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule.
Who cannot join
- Depression secondary to a general medical condition.
- History of substance abuse or dependence within the past 6 month (except nicotine and caffeine).
- All antidepressant medications, must have been in stable dosage for at least 6 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
- Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
- Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
- Presence (within 12 months of baseline) of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
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- Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the screening visit
- Use of a CYP3A4 Inhibitors and CYP3A4 Inducers within 2 weeks of screening visit.
- Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
- Known or suspected pregnancy
- Women who are breast-feeding
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
- Patients with severe respiratory insufficiency or asthma - anticipation require examination of pulmonologist.
- Patients with severe hepatic or renal insufficiency.
- Patients with history of head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis- anticipation require examination of neurologist.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata Medical Health Center
Hod HaSharon
ziv carmel, M.D., 00-972-9-7478644, zivca@clalit.org.il
About this study
Official title: A Single Center, Open Label, Dose-titration, add-on Study Assessing the Feasibility, Safety and Therapeutic Effect of Buprenorphine in Adult Patients With Diagnosis of Major Depression.
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.
- Conditions
- Depression
- Being tested
- Buprenorphine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called subutex
In the first 2 weeks all subjects will enter into a dose titration phase, starting with minimum dosage of 1mg/day Buprenorphine gradually increasing to 4-8 mg/day according to tolerance and clinical benefit.
From week 3 to week 8, all subjects are prescribed Buprenorphine sublingually, OID in a stable dosage according to the decision of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Not described Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
Measured: from baseline to day 42 [end of Buprenorphine treatment]
Secondary outcomes (1)
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.
Measured: from baseline to day 42 [end of Buprenorphine treatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startOct 2012
- Primary completionFeb 2013 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ziv carmel, M.D., Principal investigator, shalvata medical health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311570
- Sponsor's protocol ID
- B080910
- Status last verified
- Sep 2012
- First submitted
- 9 Jan 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Dose-titration, add-on Study Assessing the Feasibility, Safety and Therapeutic Effect of Buprenorphine in Adult Patients With Diagnosis of Major Depression.
- ClinicalTrials.gov ID
- NCT01311570
- Acronym / sponsor ID
- B080910
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (estimated)
- First posted
- 9 Mar 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 primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: Buprenorphine |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatients and inpatients
- Men and women 18-68 years of age.
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
- Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
- The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
Key exclusion criteria (15 listed)
- Depression secondary to a general medical condition.
- History of substance abuse or dependence within the past 6 month (except nicotine and caffeine).
- All antidepressant medications, must have been in stable dosage for at least 6 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
- Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
- Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
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 |
|---|---|---|
| BuprenorphineAlso: subutexIn the first 2 weeks all subjects will enter into a dose titration phase, starting with minimum dosage of 1mg/day Buprenorphine gradually increasing to 4-8 mg/day according to tolerance and clinical benefit. From week 3 to week 8, all subjects are prescribed Buprenorphine sublingually, OID in a stable dosage according to the decision of the treating physician. | Drug | Buprenorphine |
Primary outcome
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
Time frame: from baseline to day 42 [end of Buprenorphine treatment]
1 secondary outcome
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.
Time frame: from baseline to day 42 [end of Buprenorphine treatment]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
ziv carmel, M.D. principal investigator
shalvata medical health center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Buprenorphine in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
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 8 inclusion and 15 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 25 Sep 2012. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ziv carmel, M.D (00-972-9-7478644, zivca@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population. (time frame: from baseline to day 42 [end of Buprenorphine 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 25 Sep 2012.