Major DepressionPhase 3DEP-HOMNCT01178255
Efficacy and Safety of Homeopathy for Moderate Depression (Acute Phase)
A Phase 3 study testing homeopathic q-potencies, homeopathic case history taking type I and homeopathic case history type II in people with Major Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
To assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history taking(defined in this study as case history taking type… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- homeopathic q-potencies, homeopathic case history taking type I and homeopathic case history type II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Jul 2011
- Phase
- Phase 3
- 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
- diagnosis of major depression by a psychiatrist,
- patients must not be currently taking antidepressants or anxiolytic drugs (with the exception of Lorazepam as rescue medication, maximal dose 1.5 mg/day)
- Capability and willingness to give informed consent and to comply with the study procedures will also be required
Who cannot join
- current mild episode of depression (HAM-D < 17)
- current severe episode of depression (HAM-D > 24)
- schizophrenia or other psychotic disorders
- bipolar affective disorder
- schizoaffective disorders
- alcohol or other substance abuse
Show all 20Show fewer
- eating disorders
- a clinically significant (Diagnostic and Statistical Manual of Mental Disorders)-Axis II disorder
- severe depression, which previously motivated a suicide attempt
- a score of 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS)up to three months before screening;
- a clinically significant acute or chronic disease that would hinder regular participation in the study
- treatment with antipsychotics, antidepressants, sedatives/hypnotics or mood stabilizers four weeks prior to the screening
- complementary or alternative treatment simultaneously to the study (for example, acupuncture, phytotherapy, etc.)
- homeopathic treatment eight weeks prior to study entry
- psychotherapy
- simultaneous participation in another clinical trial (the last participation in a previous clinical trial must be completed at least three months prior to screening)
- concomitant pregnancy or breastfeeding
- patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical trial and for not complying with the necessary study procedures
- persons who have been institutionalized by a court order
- patients with an application for a pension
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin, Germany
Berlin, State of Berlin
About this study
Official title: Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM
To assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history taking(defined in this study as case history taking type I and II).
Read the detailed description
Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the taking of the case history and the prescription of an individually selected homeopathic remedy. Homeopathic medicines are produced through sequential, agitated dilutions. A Q-Potency is prepared by grinding the raw material, followed by a process of consecutive 1:50.000 agitated dilutions.
Previous data suggest that individualized homeopathic Q-potencies were non inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe major depression. The question remains whether individualized homeopathic Q-potencies have a specific therapeutical effect in acute depression as this has not yet been investigated.
- Conditions
- Major Depression
- Being tested
- homeopathic q-potencies, Placebo, homeopathic case history taking type I, homeopathic case history type II
- Keywords
- depression, homoeopathy
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homeopathic q-potenciesDrug
individualised homeopathic medicines
PlaceboDrug
placebo
homeopathic case history taking type IOther
one special homeopathic technique for case history taking
homeopathic case history type IIOther
another type of homeopathic case history taking
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: homeopathic q-potencies; Other: homeopathic case history taking type I |
| Group 2 | Experimental | Not described Receives: Drug: Placebo; Other: homeopathic case history taking type I |
| Group 3 | Experimental | Not described Receives: Drug: homeopathic q-potencies; Other: homeopathic case history type II |
| Group 4 | Experimental | Not described Receives: Drug: Placebo; Other: homeopathic case history type II |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoint is the mean total depression score post treatment
total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)
Measured: six weeks
Secondary outcomes (5)
mean total depression score during the treatment
total score on Hamilton Depression Rating Scale (HAM-D)
Measured: two and four weeks
response and remission rates
response (decrease of 50% or more from baseline HAM-D score); remission (HAM-D scores ≤ 7)
Measured: two, four and six weeks
Self-rated depression score
Beck Depression inventory (BDI) total score
Measured: two, four and six weeks
quality of life assessment
total mean score on the SF-12 Health Survey
Measured: two, four and six weeks
Safety
Adverse events will be collected during the study and will form part of the secondary endpoint data in determining the safety of homeopathic medicines. Adverse events and serious adverse events will be registered in accordance with the ICH-Guidelines for Good Clinical Practice
Measured: two, four and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M. Witt, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178255
- Sponsor's protocol ID
- DEP-HOM10
- Other IDs
- 2009-017458-11, 2009
- Acronym
- DEP-HOM
- Status last verified
- Jul 2012
- First submitted
- 9 Aug 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adler UC, Kruger S, Teut M, Ludtke R, Bartsch I, Schutzler L, Melcher F, Willich SN, Linde K, Witt CM. Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials. 2011 Feb 14;12:43. doi: 10.1186/1745-6215-12-43.
PubMed 21320338Adler UC, Kruger S, Teut M, Ludtke R, Schutzler L, Martins F, Willich SN, Linde K, Witt CM. Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM). PLoS One. 2013 Sep 23;8(9):e74537. doi: 10.1371/journal.pone.0074537. eCollection 2013.
PubMed 24086352
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathy for Depression: a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study DEP-HOM
- ClinicalTrials.gov ID
- NCT01178255
- Acronym / sponsor ID
- DEP-HOM / DEP-HOM10
- Conditions
- Major Depression
- Keywords
- depression, homoeopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Aug 2010 (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.
To assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history taking(defined in this study as case history taking type I and II).
Detailed description
Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the taking of the case history and the prescription of an individually selected homeopathic remedy. Homeopathic medicines are produced through sequential, agitated dilutions. A Q-Potency is prepared by grinding the raw material, followed by a process of consecutive 1:50.000 agitated dilutions.
Previous data suggest that individualized homeopathic Q-potencies were non inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe major depression. The question remains whether individualized homeopathic Q-potencies have a specific therapeutical effect in acute depression as this has not yet been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: homeopathic q-potencies, Other: homeopathic case history taking type I |
| Group 2 | Experimental | Drug: Placebo, Other: homeopathic case history taking type I |
| Group 3 | Experimental | Drug: homeopathic q-potencies, Other: homeopathic case history type II |
| Group 4 | Experimental | Drug: Placebo, Other: homeopathic case history type II |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of major depression by a psychiatrist,
- patients must not be currently taking antidepressants or anxiolytic drugs (with the exception of Lorazepam as rescue medication, maximal dose 1.5 mg/day)
- Capability and willingness to give informed consent and to comply with the study procedures will also be required
Key exclusion criteria (20 listed)
- current mild episode of depression (HAM-D < 17)
- current severe episode of depression (HAM-D > 24)
- schizophrenia or other psychotic disorders
- bipolar affective disorder
- schizoaffective 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 |
|---|---|---|
| homeopathic q-potenciesindividualised homeopathic medicines | Drug | Group 1, Group 3 |
| Placeboplacebo | Drug | Group 2, Group 4 |
| homeopathic case history taking type Ione special homeopathic technique for case history taking | Other | Group 1, Group 2 |
| homeopathic case history type IIanother type of homeopathic case history taking | Other | Group 3, Group 4 |
Primary outcome
primary endpoint is the mean total depression score post treatment
Time frame: six weeks
total score on the 17-item Hamilton Depression Rating Scale - (HAM-D)
5 secondary outcomes
mean total depression score during the treatment
Time frame: two and four weeks
response and remission rates
Time frame: two, four and six weeks
Self-rated depression score
Time frame: two, four and six weeks
quality of life assessment
Time frame: two, four and six weeks
Safety
Time frame: two, four and six weeks
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Background: PubMed 21320338Adler UC, Kruger S, Teut M, Ludtke R, Bartsch I, Schutzler L, Melcher F, Willich SN, Linde K, Witt CM. Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials. 2011 Feb 14;12:43. doi: 10.1186/1745-6215-12-43.
- Derived from this study: PubMed 24086352Adler UC, Kruger S, Teut M, Ludtke R, Schutzler L, Martins F, Willich SN, Linde K, Witt CM. Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM). PLoS One. 2013 Sep 23;8(9):e74537. doi: 10.1371/journal.pone.0074537. eCollection 2013.
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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.
Claudia M. Witt, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing homeopathic q-potencies, homeopathic case history taking type I and homeopathic case history type II in people with Major Depression, run by Charite University, Berlin, Germany at 1 site 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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 10 Jul 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
primary endpoint is the mean total depression score post treatment (time frame: six weeks). 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 NCT01178255, which also lists 2 linked publications.
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 Jul 2012.