Major DepressionPhase 1NCT00472576
Antidepressant Effects of NR2B in Major Depression
A Phase 1 study testing MK-0657 in people with Major Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depression
- What is being tested?
- MK-0657
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female (not of reproductive potential, unable to conceive) subjects, 18 to 55 years of age. A female patient not of reproductive potential is defined as one who: a) has reached menopause with: i) no menses for the past 3 or more years OR ii) no menses for greater than 1 year but less than 3 years with confirmation of FSH levels elevated into the postmenopausal range; or b) has undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Subjects must fulfill DSM-IV criteria for Major Depression (296.3) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
- Subjects must have an initial score of at least 22 on the MADRS at screen and at baseline of study phase II.
- Current or past history of lack of response to two adequate antidepressant trials (may be from the same chemical class) operationally defined using the Antidepressant Treatment History Form (ATHF). If subjects have only failed to respond to one adequate antidepressant trial by history, they will be permitted to receive a prospective trial of a standard antidepressant. Subjects who fail to respond to this prospective trial will meet criteria for treatment-resistance and be eligible to randomize. Subjects responding to the prospective trial will be ineligible to randomize. (A CORE representative will be present when the subject is informed as to the decision to randomize or not).
- Current major depressive episode of at least 4 weeks duration.
Who cannot join
- Current or past history of bipolar disorder, psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
- Subjects with a history of DSM-IV drug or alcohol dependency or abuse (including for nicotine and caffeine) within the preceding 3 months.
- Subjects with a diagnosis of Obsessive Compulsive Disorder or Posttraumatic Stress Disorder as defined in the DSM-IV.
- Subjects with a diagnosis of Borderline or Antisocial Personality disorder. Other Axis II disorders do not qualify one for exclusion from the study.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Patient has a history of any cardiovascular disease, including myocardial infarction, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease.
Show all 16Show fewer
- Patient has systolic blood pressure of less than 90 mm Hg or greater than 135 mm Hg at the screen visit or has orthostatic hypotension at the screen visit (greater than or equal to 20 mm Hg decline in systolic blood pressure compared with previous supine systolic blood pressure plus orthostatic symptoms within 3 minutes after standing).
- Clinically significant abnormal laboratory test or electrocardiogram.
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
- Subjects with one or more seizures without a clear and resolved etiology.
- Previous lack of antidepressant response to ketamine or hypersensitivity to ketamine or amantadine.
- Treatment with fluoxetine within 5 weeks prior to study phase I.
- Treatment with any other concomitant medication not allowed 7 days (14 days for MAOIs) prior to study phase II.
- Treatment with clozapine or ECT within 2 months prior to study phase II.
- MADRS greater than 4 on item 10 (suicidal ideation).
- No structured psychotherapy will be permitted during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: An Investigation of the Antidepressant Effects of the Selective NR2B Antagonist MK-0657 in Major Depression
Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression.
MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded. Participants are admitted to the NIH Clinical Center for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their current medications. Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657. Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day.
Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.
Read the detailed description
Even though there are many antidepressant drugs for clinical use, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatments despite adequate dosage, duration, and compliance. Furthermore, these medications may take weeks to months to achieve their full effects and in the meantime, patients continue to suffer from their symptoms and be at risk of self-harm as well as harm to their personal and professional lives. Thus, there is a clear need to develop novel and improved therapeutics for treatment-resistant major depression that have a rapid onset of action. Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system, specifically on the NMDA receptor complex. A recent study by our group found that a single intravenous dose of the non-competitive NMDA antagonist ketamine produced a rapid, robust and relatively sustained antidepressant effect in patients with treatment-resistant major depression. Together, these data suggest that the NMDA receptor may play an important role in the mechanism of antidepressant action. Unfortunately, ketamine's psychotomimetic effects preclude its use as a chronic antidepressant; these side effects probably are a result of ketamine's effects on multiple NMDA subunits. Thus, studying selective NMDA subunit antagonists in depression is a reasonable next step. The NR2B subunit stands as a prime candidate to test in depression. Preclinical data by our group indicates that the NR2B subunit is involved in the mechanism of antidepressant action as indicated by changes in phosphorylation of serine residues in the learned helplessness model of depression and with chronic treatment with imipramine. In addition, we found that the NR2B antagonist R0 25-6981 has antidepressant-like properties in the forced swim test. We propose to examine whether the selective NR2B antagonist (MK-0657) produces rapid antidepressant effects in patients with treatment-resistant major depression but without causing psychotomimetic effects.
Male and female patients, ages 18 to 55 years, with a diagnosis of major depression (without psychotic features), will be recruited for this study. This study consists of the double-blind crossover administration of either the NR2B antagonist MK-0657 (4-8 mg/day) or placebo.
The specific aim of this study is to assess the efficacy of 12 days of a selective NR2B antagonist (MK-0657, 4-8 mg/day given orally) compared with placebo in improving overall depressive symptomatology in patients with treatment-resistant major depression.
Our primary hypothesis is that subjects with treatment-resistant major depression who are randomized to a selective NR2B antagonist (MK-0657) will have a more rapid and superior response compared to when they are randomized to placebo. This is a proof of concept and treatment study.
Approximately, 27 subjects will be randomized; the accrual ceiling for this protocol is 60 subjects.
- Conditions
- Major Depression
- Being tested
- MK-0657, Placebo
- Keywords
- NMDA Receptor, Depression Treatment, Unipolar Depression, Treatment Resistant, Glutamatergic, Depression, Major Depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0657Drug
Also called NR2B antagonist
Daily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day)
PlaceboDrug
Also called Inactive drug
Daily double-blind administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo then MK-0657 | Experimental | Double-blind crossover administration of placebo then MK-0657 (4-8 mg/day) Receives: Drug: MK-0657; Drug: Placebo |
| MK-0657 then Placebo | Experimental | Double-blind crossover administration of MK-0657 (4-8 mg/day) then placebo Receives: Drug: MK-0657; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.
Measured: Measured daily for 12 days, where the endpoint is the primary outcome
Secondary outcomes (1)
Hamilton Depression Rating Scale (HDRS)
The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.
Measured: Measured daily for 12 days, where the endpoint is primary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 National Institute of Mental Health (NIMH)The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Carlos A Zarate, MD, Principal investigator, Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472576
- Sponsor's protocol ID
- 070152
- Other IDs
- 07-M-0152
- Status last verified
- Jul 2012
- First submitted
- 10 May 2007
- Last updated
- 3 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.
PubMed 4899510Adamec RE, Burton P, Shallow T, Budgell J. Unilateral block of NMDA receptors in the amygdala prevents predator stress-induced lasting increases in anxiety-like behavior and unconditioned startle--effective hemisphere depends on the behavior. Physiol Behav. 1999 Jan 1-15;65(4-5):739-51. doi: 10.1016/s0031-9384(98)00225-x.
PubMed 10073475Aguado L, San Antonio A, Perez L, del Valle R, Gomez J. Effects of the NMDA receptor antagonist ketamine on flavor memory: conditioned aversion, latent inhibition, and habituation of neophobia. Behav Neural Biol. 1994 May;61(3):271-81. doi: 10.1016/s0163-1047(05)80010-x.
PubMed 8067982Ibrahim L, Diaz Granados N, Jolkovsky L, Brutsche N, Luckenbaugh DA, Herring WJ, Potter WZ, Zarate CA Jr. A Randomized, placebo-controlled, crossover pilot trial of the oral selective NR2B antagonist MK-0657 in patients with treatment-resistant major depressive disorder. J Clin Psychopharmacol. 2012 Aug;32(4):551-7. doi: 10.1097/JCP.0b013e31825d70d6.
PubMed 22722512
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Antidepressant Effects of the Selective NR2B Antagonist MK-0657 in Major Depression
- ClinicalTrials.gov ID
- NCT00472576
- Acronym / sponsor ID
- 070152
- Conditions
- Major Depression
- Keywords
- NMDA Receptor, Depression Treatment, Unipolar Depression, Treatment Resistant, Glutamatergic, Depression, Major Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Posted 7 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression.
MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded. Participants are admitted to the NIH Clinical Center for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their current medications. Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657. Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day.
Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.
Detailed description
Even though there are many antidepressant drugs for clinical use, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatments despite adequate dosage, duration, and compliance. Furthermore, these medications may take weeks to months to achieve their full effects and in the meantime, patients continue to suffer from their symptoms and be at risk of self-harm as well as harm to their personal and professional lives. Thus, there is a clear need to develop novel and improved therapeutics for treatment-resistant major depression that have a rapid onset of action. Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system, specifically on the NMDA receptor complex. A recent study by our group found that a single intravenous dose of the non-competitive NMDA antagonist ketamine produced a rapid, robust and relatively sustained antidepressant effect in patients with treatment-resistant major depression. Together, these data suggest that the NMDA receptor may play an important role in the mechanism of antidepressant action. Unfortunately, ketamine's psychotomimetic effects preclude its use as a chronic antidepressant; these side effects probably are a result of ketamine's effects on multiple NMDA subunits. Thus, studying selective NMDA subunit antagonists in depression is a reasonable next step. The NR2B subunit stands as a prime candidate to test in depression. Preclinical data by our group indicates that the NR2B subunit is involved in the mechanism of antidepressant action as indicated by changes in phosphorylation of serine residues in the learned helplessness model of depression and with chronic treatment with imipramine. In addition, we found that the NR2B antagonist R0 25-6981 has antidepressant-like properties in the forced swim test. We propose to examine whether the selective NR2B antagonist (MK-0657) produces rapid antidepressant effects in patients with treatment-resistant major depression but without causing psychotomimetic effects.
Male and female patients, ages 18 to 55 years, with a diagnosis of major depression (without psychotic features), will be recruited for this study. This study consists of the double-blind crossover administration of either the NR2B antagonist MK-0657 (4-8 mg/day) or placebo.
The specific aim of this study is to assess the efficacy of 12 days of a selective NR2B antagonist (MK-0657, 4-8 mg/day given orally) compared with placebo in improving overall depressive symptomatology in patients with treatment-resistant major depression.
Our primary hypothesis is that subjects with treatment-resistant major depression who are randomized to a selective NR2B antagonist (MK-0657) will have a more rapid and superior response compared to when they are randomized to placebo. This is a proof of concept and treatment study.
Approximately, 27 subjects will be randomized; the accrual ceiling for this protocol is 60 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then MK-0657 | Experimental | Drug: MK-0657, Drug: PlaceboDouble-blind crossover administration of placebo then MK-0657 (4-8 mg/day) |
| MK-0657 then Placebo | Experimental | Drug: MK-0657, Drug: PlaceboDouble-blind crossover administration of MK-0657 (4-8 mg/day) then placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female (not of reproductive potential, unable to conceive) subjects, 18 to 55 years of age. A female patient not of reproductive potential is defined as one who: a) has reached menopause with: i) no menses for the past 3 or more years OR ii) no menses for greater than 1 year but less than 3 years with confirmation of FSH levels elevated into the postmenopausal range; or b) has undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Subjects must fulfill DSM-IV criteria for Major Depression (296.3) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
- Subjects must have an initial score of at least 22 on the MADRS at screen and at baseline of study phase II.
- Current or past history of lack of response to two adequate antidepressant trials (may be from the same chemical class) operationally defined using the Antidepressant Treatment History Form (ATHF). If subjects have only failed to respond to one adequate antidepressant trial by history, they will be permitted to receive a prospective trial of a standard antidepressant. Subjects who fail to respond to this prospective trial will meet criteria for treatment-resistance and be eligible to randomize. Subjects responding to the prospective trial will be ineligible to randomize. (A CORE representative will be present when the subject is informed as to the decision to randomize or not).
Key exclusion criteria (16 listed)
- Current or past history of bipolar disorder, psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
- Subjects with a history of DSM-IV drug or alcohol dependency or abuse (including for nicotine and caffeine) within the preceding 3 months.
- Subjects with a diagnosis of Obsessive Compulsive Disorder or Posttraumatic Stress Disorder as defined in the DSM-IV.
- Subjects with a diagnosis of Borderline or Antisocial Personality disorder. Other Axis II disorders do not qualify one for exclusion from the study.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
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 |
|---|---|---|
| MK-0657Also: NR2B antagonistDaily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day) | Drug | MK-0657 then Placebo, Placebo then MK-0657 |
| PlaceboAlso: Inactive drugDaily double-blind administration of placebo | Drug | MK-0657 then Placebo, Placebo then MK-0657 |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Measured daily for 12 days, where the endpoint is the primary outcome
The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.
1 secondary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: Measured daily for 12 days, where the endpoint is primary
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4899510Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.
- Background: PubMed 10073475Adamec RE, Burton P, Shallow T, Budgell J. Unilateral block of NMDA receptors in the amygdala prevents predator stress-induced lasting increases in anxiety-like behavior and unconditioned startle--effective hemisphere depends on the behavior. Physiol Behav. 1999 Jan 1-15;65(4-5):739-51. doi: 10.1016/s0031-9384(98)00225-x.
- Background: PubMed 8067982Aguado L, San Antonio A, Perez L, del Valle R, Gomez J. Effects of the NMDA receptor antagonist ketamine on flavor memory: conditioned aversion, latent inhibition, and habituation of neophobia. Behav Neural Biol. 1994 May;61(3):271-81. doi: 10.1016/s0163-1047(05)80010-x.
- Derived from this study: PubMed 22722512Ibrahim L, Diaz Granados N, Jolkovsky L, Brutsche N, Luckenbaugh DA, Herring WJ, Potter WZ, Zarate CA Jr. A Randomized, placebo-controlled, crossover pilot trial of the oral selective NR2B antagonist MK-0657 in patients with treatment-resistant major depressive disorder. J Clin Psychopharmacol. 2012 Aug;32(4):551-7. doi: 10.1097/JCP.0b013e31825d70d6.
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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.
Carlos A Zarate, MD principal investigator
Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
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 MK-0657 in people with Major Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
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 6 inclusion and 16 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 3 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Measured daily for 12 days, where the endpoint is the primary outcome). 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 NCT00472576, which also lists 4 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 3 Aug 2012.