Major Depressive EpisodeNCT03190772
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
A study testing Film sequence in people with Major Depressive Episode, run by Philipps University Marburg at 2 sites in Germany.
Trial summary
The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Film sequence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Nov 2017to 30 Sep 2018
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- major depression (mild to moderate)
- fluent in German language
Who cannot join
- bipolar disorder, psychotic disorder, substance dependence
- cardiovascular disease, severe kidney or liver disease, epilepsy
- change of psychotropic medication intake within the last four weeks
- allergic to capsaicin
- allergic to sesame oil
- students in medicine, pharmacy, or psychology in their third year or older
- completed studies in medicine, pharmacy or psychology
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Justus Liebig University Gießen
Giessen, Hesse, 35390
Philipps University Marburg
Marburg, Hesse, 35032
About this study
The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.
- Conditions
- Major Depressive Episode
- Being tested
- Placebo nasal spray, Film sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo nasal sprayOther
The placebo nasal spray consists of sesame oil and does not contain any active drug.
Film sequenceOther
All groups watch the film sequence that is supposed to induce sadness.
| Study group | Role | What they receive |
|---|---|---|
| Positive placebo group | Experimental | Participants receive a placebo nasal spray. However, they are told that it protects from experiencing negative emotions. Participants watch a film sequence that is supposed to induce sadness. Receives: Other: Placebo nasal spray; Other: Film sequence |
| Placebo control group | Placebo comparator | Participants receive a placebo nasal spray and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness. Receives: Other: Placebo nasal spray; Other: Film sequence |
| No-treatment control group | Other | Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness. Receives: Other: Film sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sadness
Items of PANAS-X
Measured: Directly after watching the film sequence, no follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Nov 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Professor, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190772
- Sponsor's protocol ID
- 2017-12k
- Status last verified
- Nov 2018
- First submitted
- 14 Jun 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
- ClinicalTrials.gov ID
- NCT03190772
- Acronym / sponsor ID
- 2017-12k
- Conditions
- Major Depressive Episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Jun 2017 (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.
The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive placebo group | Experimental | Other: Placebo nasal spray, Other: Film sequenceParticipants receive a placebo nasal spray. However, they are told that it protects from experiencing negative emotions. Participants watch a film sequence that is supposed to induce sadness. |
| Placebo control group | Placebo comparator | Other: Placebo nasal spray, Other: Film sequenceParticipants receive a placebo nasal spray and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness. |
| No-treatment control group | Other | Other: Film sequenceParticipants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major depression (mild to moderate)
- fluent in German language
Key exclusion criteria (7 listed)
- bipolar disorder, psychotic disorder, substance dependence
- cardiovascular disease, severe kidney or liver disease, epilepsy
- change of psychotropic medication intake within the last four weeks
- allergic to capsaicin
- allergic to sesame oil
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 |
|---|---|---|
| Placebo nasal sprayThe placebo nasal spray consists of sesame oil and does not contain any active drug. | Other | Placebo control group, Positive placebo group |
| Film sequenceAll groups watch the film sequence that is supposed to induce sadness. | Other | No-treatment control group, Placebo control group, Positive placebo group |
Primary outcome
Sadness
Time frame: Directly after watching the film sequence, no follow-up assessments
Items of PANAS-X
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 7 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Winfried Rief, Professor principal investigator
Philipps University Marburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Film sequence in people with Major Depressive Episode, run by Philipps University Marburg at 2 sites in Germany.
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 7 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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?
Sadness (time frame: Directly after watching the film sequence, no follow-up assessments). 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 7 Nov 2018.