Major Depressive Disorder (MDD)Phase 3NCT00958204
Light, Ion, and Fluoxetine Efficacy (LIFE) in Depression
A Phase 3 study testing Light treatment, Negative ion therapy and Fluoxetine in people with Major Depressive Disorder (MDD), run by University of British Columbia at 1 site in Canada.
Trial summary
This study will investigate the additional benefits of light and ion therapy as added treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder (MDD), versus treatment with fluoxetine alone. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Light treatment, Negative ion therapy and Fluoxetine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to May 2014
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female outpatients aged 19-60 years.
- Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).
- A score of 20 or greater on the Hamilton Depression Rating Scale (Ham-D), indicating at least moderately severe depression.
- Competency to give informed consent.
Who cannot join
- Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
- Serious suicidal risks as judged by the clinician and the MINI.
- The following DSM-IV diagnoses (to ensure a homogeneous diagnostic group): organic mental disorders; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid, or delusional disorders; other psychotic disorders; panic disorder or generalized anxiety disorder, if a primary diagnosis; obsessive-compulsive disorder or post-traumatic stress disorder; bipolar disorder; bulimia nervosa or anorexia nervosa.
- Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized, or a past history of convulsions.
- Any retinal disease or systemic illness with active retinal involvement (e.g. diabetes) that precludes the use of bright light.
- Patients who have a history of severe allergies and multiple drug adverse reactions.
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- Regular or current use of other psychotropic drugs, including lithium and tryptophan.
- Patients treated with beta blocking drugs.
- Hypertensive patients being treated with guanethidine, reserpine, clonidine or methyldopa (because of possible mood-altering effects of those drugs).
- Use of monoamine oxidase inhibitors within 14 days of Visit 1 (to ensure no drug interactions between fluoxetine and MAOIs), or use of heterocyclic antidepressants within 7 days of Visit 1 (to ensure adequate washout period of two weeks between stopping previous drug and start of treatment at Visit 2).
- Previous use of fluoxetine or light therapy.
- Treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.
- Patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of Visit 1, or who plan to initiate such psychotherapy during this study.
- Patients involved in any other form of treatment for depression.
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Hospital Mood Disorders Centre
Vancouver, British Columbia, V6T 2A1
About this study
Official title: Light and Ion Treatment to Enhance Medication Efficacy in Depression
This study will investigate the additional benefits of light and ion therapy as added treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder (MDD), versus treatment with fluoxetine alone. Outcomes will include depressive symptom rating scales and measures of quality of life, work absence and productivity, and use of health care services. The primary hypotheses are that, in patients with nonseasonal major depressive disorder (MDD) of at least moderate severity: 1) bright light therapy or negative ion therapy will be superior to a placebo condition in reducing symptoms of depression, and 2) the combination of fluoxetine and either bright light or negative ion therapy is more effective than either monotherapy condition.
Read the detailed description
Rationale
Many effective treatments exist for depression, including psychotherapies and antidepressant medications. However, antidepressants are not always effective, and they can produce significant side effects and pose a risk of overdose. Medication can also be expensive, thereby limiting accessibility. Furthermore, many people with MDD prefer to use non-pharmacological treatments. Some studies have found that combination antidepressant and psychotherapy is more effective than either monotherapy in people with chronic forms of MDD. However, evidence-based psychotherapies such as cognitive-behavioural therapy are not widely available within the Canadian health care system.
For these reasons, there is great interest in finding alternative treatments to antidepressants and psychotherapy. Bright light therapy, which is well established as an effective treatment for seasonal affective disorder (SAD), has many attributes that make it highly attractive to use for nonseasonal MDD: it is a safe, well-tolerated, inexpensive, easy to use, non-pharmacological treatment that can be used as monotherapy or combined with medications without the worry of drug-drug interactions. The "gold standard" method for applying light therapy is via a 10,000 lux white fluorescent light box for 30 minutes a day, usually in the early morning upon arising from bed. The mechanism of action of light therapy is still unknown, but major hypotheses involve resynchronizing circadian rhythms and/or restoring neurotransmitter dysfunction. Bright light has predictable phase-shifting effects on circadian rhythms in humans, but studies of light therapy have not consistently demonstrated correlations of phase shift with antidepressant response. Although most of these studies have been done in patients with SAD, there is considerable evidence that nonseasonal MDD is also associated with disturbances in circadian rhythms. Other studies have shown that rapidly depleting serotonin and catecholamines can reverse the antidepressant effects of light therapy in SAD, thereby demonstrating monoaminergic effects of bright light similar to those seen with antidepressants. These chronobiologic and monoaminergic effects of bright light provide a rationale for the use of light therapy in nonseasonal MDD. As well, initial studies have shown that negative ion generators may be an effective treatment for neurovegetative symptoms of SAD, specifically oversleeping, overeating, and fatigability. However, relatively few studies have been conducted of light and ion therapy in nonseasonal MDD. Several systematic reviews of light and ion therapy for nonseasonal MDD have shown some support for efficacy, but these are based on a limited number of small-sample, poorly controlled RCTs.
Research Method
This study is an 8-week, multi-centre, double-blind (subject and rater), randomized, parallel-design trial to assess the efficacy of light and ion therapy when combined with fluoxetine in the treatment of subjects with MDD, compared to treatment with fluoxetine alone. A total of 216 depressed patients meeting entry criteria will be enrolled over a three-year period.
Eligible patients will be randomized to one of four treatment conditions for the entire treatment period (8 weeks):
- light treatment using a fluorescent light box (30 minutes daily) plus a placebo pill every day; or
- negative ion generator (30 minutes daily) plus 20 mg of fluoxetine per day; or
- negative ion generator (30 minutes daily) plus placebo pill every day; or
- light treatment using a fluorescent light box (30 minutes daily) plus 20 mg of fluoxetine per day.
Half of all devices (light boxes and negative ions) will be deactivated to test placebo conditions.
Outcomes (HAM-D) will be primarily assessed over the telephone by raters blind to treatment assignment. Other outcome measures will be assessed by patient-rated questionnaires administered over the Internet using a secure web site, and by ratings from the treating physician (CGI and Health Economics Assessment).
Statistical Analysis All randomized subjects who have at least one follow-up visit will be included in the analysis based on intent-to-treat. Ineligible subjects who are inappropriately randomized will be excluded from the analysis. Missing data will be imputed using last observation carried forward (LOCF). For the analyses the treatment variables will remain coded and the analysts and investigators will remain blinded to variable identity during analysis and interpretation.
The pre-specified primary efficacy endpoint is the adjusted mean change from baseline to endpoint (8 weeks) in the HAM-D score using LOCF. All comparisons will be analyzed using ANCOVA adjusting for baseline value and centre. The secondary outcomes will also be analyzed using a similar analysis, when appropriate. Post-hoc analyses will also examine observed case data. Categorical data (such as proportions of the sample with adverse events) will be analyzed using chi-square tests or Fisher's test where cell sizes warrant.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Light treatment, Negative ion therapy, Placebo, Fluoxetine
- Keywords
- Depression, rating scales, RCT, combination treatment, light therapy, negative ion therapy, fluoxetine, antidepressants
- 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.
Light treatmentProcedure or surgery
Light therapy: from a 10,000 lux fluorescent white light box, for 30 minutes per day upon waking in the morning, for 8 weeks.
Negative ion therapyProcedure or surgery
Negative ion therapy: from a negative ion generator with an output of 200 trillion ions per second per cubic centimeter, for 30 minutes per day upon waking in the morning, for 8 weeks
PlaceboDrug
Placebo Pill: one oral tablet each day, for 8 weeks.
FluoxetineDrug
Fluoxetine: 20 mg oral tablet each day, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Light treatment using a fluorescent light box (30 minutes daily) plus a placebo pill every day Receives: Procedure: Light treatment; Drug: Placebo |
| 2 | Experimental | Negative ion generator (30 minutes daily) plus 20 mg of fluoxetine per day Receives: Procedure: Negative ion therapy; Drug: Fluoxetine |
| 3 | Active comparator | Light treatment using a fluorescent light box (30 minutes daily) plus 20 mg of fluoxetine per day Receives: Procedure: Light treatment; Drug: Fluoxetine |
| 4 | Placebo comparator | Negative ion generator (30 minutes daily) plus placebo pill every day Receives: Procedure: Negative ion therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adjusted HAM-D scores at 2-month follow-up.
Measured: 2 months
Secondary outcomes (1)
At 2-month follow-up: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and health services.
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 posted13 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2014
- Study completionMay 2014
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 Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Serge Beaulieu, Dr., Study director, McGill UniversityAmy HY Cheung, Dr., Study director, University of TorontoAlexander J. Kiss, Dr., Study director, Sunnybrook Health Sciences CentreRobert D. Levitan, Dr., Study director, University of TorontoAnthony J. Levitt, Dr., Study director, University of TorontoErin E. Michalak, Dr., Study director, University of British ColumbiaRachel L. Morehouse, Dr., Study director, Dalhousie UniversitySagar V. Parikh, Dr., Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958204
- Sponsor's protocol ID
- H09-01015
- Status last verified
- Jun 2014
- First submitted
- 11 Aug 2009
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levitan RD, Levitt AJ, Michalak EE, Morehouse R, Ramasubbu R, Yatham LN, Tam EM, Lam RW. Appetitive Symptoms Differentially Predict Treatment Response to Fluoxetine, Light, and Placebo in Nonseasonal Major Depression. J Clin Psychiatry. 2018 Jul 24;79(4):17m11856. doi: 10.4088/JCP.17m11856.
PubMed 30063303Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.
PubMed 26580307
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light and Ion Treatment to Enhance Medication Efficacy in Depression
- ClinicalTrials.gov ID
- NCT00958204
- Acronym / sponsor ID
- H09-01015
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Depression, rating scales, RCT, combination treatment, light therapy, negative ion therapy, fluoxetine, antidepressants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Aug 2009 (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.
This study will investigate the additional benefits of light and ion therapy as added treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder (MDD), versus treatment with fluoxetine alone. Outcomes will include depressive symptom rating scales and measures of quality of life, work absence and productivity, and use of health care services. The primary hypotheses are that, in patients with nonseasonal major depressive disorder (MDD) of at least moderate severity: 1) bright light therapy or negative ion therapy will be superior to a placebo condition in reducing symptoms of depression, and 2) the combination of fluoxetine and either bright light or negative ion therapy is more effective than either monotherapy condition.
Detailed description
Rationale
Many effective treatments exist for depression, including psychotherapies and antidepressant medications. However, antidepressants are not always effective, and they can produce significant side effects and pose a risk of overdose. Medication can also be expensive, thereby limiting accessibility. Furthermore, many people with MDD prefer to use non-pharmacological treatments. Some studies have found that combination antidepressant and psychotherapy is more effective than either monotherapy in people with chronic forms of MDD. However, evidence-based psychotherapies such as cognitive-behavioural therapy are not widely available within the Canadian health care system.
For these reasons, there is great interest in finding alternative treatments to antidepressants and psychotherapy. Bright light therapy, which is well established as an effective treatment for seasonal affective disorder (SAD), has many attributes that make it highly attractive to use for nonseasonal MDD: it is a safe, well-tolerated, inexpensive, easy to use, non-pharmacological treatment that can be used as monotherapy or combined with medications without the worry of drug-drug interactions. The "gold standard" method for applying light therapy is via a 10,000 lux white fluorescent light box for 30 minutes a day, usually in the early morning upon arising from bed. The mechanism of action of light therapy is still unknown, but major hypotheses involve resynchronizing circadian rhythms and/or restoring neurotransmitter dysfunction. Bright light has predictable phase-shifting effects on circadian rhythms in humans, but studies of light therapy have not consistently demonstrated correlations of phase shift with antidepressant response. Although most of these studies have been done in patients with SAD, there is considerable evidence that nonseasonal MDD is also associated with disturbances in circadian rhythms. Other studies have shown that rapidly depleting serotonin and catecholamines can reverse the antidepressant effects of light therapy in SAD, thereby demonstrating monoaminergic effects of bright light similar to those seen with antidepressants. These chronobiologic and monoaminergic effects of bright light provide a rationale for the use of light therapy in nonseasonal MDD. As well, initial studies have shown that negative ion generators may be an effective treatment for neurovegetative symptoms of SAD, specifically oversleeping, overeating, and fatigability. However, relatively few studies have been conducted of light and ion therapy in nonseasonal MDD. Several systematic reviews of light and ion therapy for nonseasonal MDD have shown some support for efficacy, but these are based on a limited number of small-sample, poorly controlled RCTs.
Research Method
This study is an 8-week, multi-centre, double-blind (subject and rater), randomized, parallel-design trial to assess the efficacy of light and ion therapy when combined with fluoxetine in the treatment of subjects with MDD, compared to treatment with fluoxetine alone. A total of 216 depressed patients meeting entry criteria will be enrolled over a three-year period.
Eligible patients will be randomized to one of four treatment conditions for the entire treatment period (8 weeks):
- light treatment using a fluorescent light box (30 minutes daily) plus a placebo pill every day; or
- negative ion generator (30 minutes daily) plus 20 mg of fluoxetine per day; or
- negative ion generator (30 minutes daily) plus placebo pill every day; or
- light treatment using a fluorescent light box (30 minutes daily) plus 20 mg of fluoxetine per day.
Half of all devices (light boxes and negative ions) will be deactivated to test placebo conditions.
Outcomes (HAM-D) will be primarily assessed over the telephone by raters blind to treatment assignment. Other outcome measures will be assessed by patient-rated questionnaires administered over the Internet using a secure web site, and by ratings from the treating physician (CGI and Health Economics Assessment).
Statistical Analysis All randomized subjects who have at least one follow-up visit will be included in the analysis based on intent-to-treat. Ineligible subjects who are inappropriately randomized will be excluded from the analysis. Missing data will be imputed using last observation carried forward (LOCF). For the analyses the treatment variables will remain coded and the analysts and investigators will remain blinded to variable identity during analysis and interpretation.
The pre-specified primary efficacy endpoint is the adjusted mean change from baseline to endpoint (8 weeks) in the HAM-D score using LOCF. All comparisons will be analyzed using ANCOVA adjusting for baseline value and centre. The secondary outcomes will also be analyzed using a similar analysis, when appropriate. Post-hoc analyses will also examine observed case data. Categorical data (such as proportions of the sample with adverse events) will be analyzed using chi-square tests or Fisher's test where cell sizes warrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Light treatment, Drug: PlaceboLight treatment using a fluorescent light box (30 minutes daily) plus a placebo pill every day |
| 2 | Experimental | Procedure: Negative ion therapy, Drug: FluoxetineNegative ion generator (30 minutes daily) plus 20 mg of fluoxetine per day |
| 3 | Active comparator | Procedure: Light treatment, Drug: FluoxetineLight treatment using a fluorescent light box (30 minutes daily) plus 20 mg of fluoxetine per day |
| 4 | Placebo comparator | Procedure: Negative ion therapy, Drug: PlaceboNegative ion generator (30 minutes daily) plus placebo pill every day |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female outpatients aged 19-60 years.
- Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).
- A score of 20 or greater on the Hamilton Depression Rating Scale (Ham-D), indicating at least moderately severe depression.
- Competency to give informed consent.
Key exclusion criteria (14 listed)
- Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
- Serious suicidal risks as judged by the clinician and the MINI.
- The following DSM-IV diagnoses (to ensure a homogeneous diagnostic group): organic mental disorders; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid, or delusional disorders; other psychotic disorders; panic disorder or generalized anxiety disorder, if a primary diagnosis; obsessive-compulsive disorder or post-traumatic stress disorder; bipolar disorder; bulimia nervosa or anorexia nervosa.
- Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized, or a past history of convulsions.
- Any retinal disease or systemic illness with active retinal involvement (e.g. diabetes) that precludes the use of bright light.
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 |
|---|---|---|
| Light treatmentLight therapy: from a 10,000 lux fluorescent white light box, for 30 minutes per day upon waking in the morning, for 8 weeks. | Procedure or surgery | 1, 3 |
| Negative ion therapyNegative ion therapy: from a negative ion generator with an output of 200 trillion ions per second per cubic centimeter, for 30 minutes per day upon waking in the morning, for 8 weeks | Procedure or surgery | 2, 4 |
| PlaceboPlacebo Pill: one oral tablet each day, for 8 weeks. | Drug | 1, 4 |
| FluoxetineFluoxetine: 20 mg oral tablet each day, for 8 weeks | Drug | 2, 3 |
Primary outcome
Change in adjusted HAM-D scores at 2-month follow-up.
Time frame: 2 months
1 secondary outcome
At 2-month follow-up: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and health services.
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 6 Jun 2014.
- Derived from this study: PubMed 30063303Levitan RD, Levitt AJ, Michalak EE, Morehouse R, Ramasubbu R, Yatham LN, Tam EM, Lam RW. Appetitive Symptoms Differentially Predict Treatment Response to Fluoxetine, Light, and Placebo in Nonseasonal Major Depression. J Clin Psychiatry. 2018 Jul 24;79(4):17m11856. doi: 10.4088/JCP.17m11856.
- Derived from this study: PubMed 26580307Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.
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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.
Serge Beaulieu, Dr. study director
McGill University
Amy HY Cheung, Dr. study director
University of Toronto
Alexander J. Kiss, Dr. study director
Sunnybrook Health Sciences Centre
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 Light treatment, Negative ion therapy and Fluoxetine in people with Major Depressive Disorder (MDD), run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 14 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 6 Jun 2014. 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 Canada. 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 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 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?
Change in adjusted HAM-D scores at 2-month follow-up. (time frame: 2 months). 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 NCT00958204, 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 6 Jun 2014.