HealthyNCT03965247
Lithium Effects on Reward Processing and Reappraisal in Healthy Volunteers
A study testing Lithium in people with Healthy, run by University of Oxford.
Trial summary
Bipolar disorder has been associated with blunted activity in regions associated with emotional processing, such as striatal activity during reward anticipation as well as prefrontal activity during reappraisal. Lithium is the most effective treatment in bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lithium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2011to 4 Sep 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is willing and able to give informed consent for participation in the study.
- Subject is between 18 and 55 years of age
- Subject has a body mass index (BMI) in the range of 19-30
- Subjects will be physically fit, as assessed by a physical examination by a medical doctor.
- if female and of child bearing age must have a negative pregnancy test for inclusion and must be using two forms of effective contraception.
- Subjects will be fluent English speakers
Show all 9Show fewer
- Thyroid stimulating hormone and creatinine will be assessed pre-treatment to ensure that these are within healthy range
- non or light smoker < 5 cigarettes per day
- right handed
Who cannot join
- taking psychotropic medication
- any past or current axis 1 psychiatric disorder on DSM-IV
- Any medical contra-indication (for example, conditions that might alter absorption of lithium or which could impact on the safety of the druk for the volunteer, for example impaired renal function as assessed by creatinine levels or impaired thyroid function as assessed by thyroid stimulating hormone levels)
- Current pregnancy or breastfeeding
- Current or past history of drug or alcohol dependency
- Participant in a psychological or medical study involving the medication within the last 3 months
Show all 10Show fewer
- Smoker > 5 cigarettes per day
- Dyslexia
- Any contra-indication to MRI scanning, for example chance of metal in the body
- Left-handed
About this study
Official title: The Effects of Short-term Lithium Administration on Striatal Reward Processing and Prefrontal Control During Reappraisal in Healthy Volunteers
Bipolar disorder has been associated with blunted activity in regions associated with emotional processing, such as striatal activity during reward anticipation as well as prefrontal activity during reappraisal. Lithium is the most effective treatment in bipolar disorder. Neurochemical and molecular basis of lithium is well known, but how this translates to mood stabilisation is not understood. This study is designed to address how lithium influences reward and emotion regulation processes in humans.
Read the detailed description
Background:
Bipolar disorder is a relatively common psychiatric disorder for which treatment options are limited. The so-called mood stabiliser, lithium (usually in the form of lithium carbonate) is one of the most commonly used treatments for the disorder, and is effective in treating both acute mania and as a long term maintenance treatment. The investigator's understanding of the pharmacological mechanisms by which lithium exerts its actions is fairly well developed, however there is a lack of understanding of the psychological mechanisms. Within this study the investigators will look at two different types of emotional processing, namely reward anticipation/feedback and emotion regulation, to gain more understanding on how lithium exerts its mood stabilising effects.
Reward processing:
The neural correlates underlying reward anticipation and feedback can be measured with the Monetary Incentive Delay (MID) task, a widely used task for different disorders. Reward anticipation during the MID task has been associated among others, with ventral and dorsal striatum activity. Most critically, bipolar disorder has been associated with blunted reward function of the medial caudate. Reward feedback has been associated with ventral striatum and OFC/vmPFC activity.
Emotion regulation:
One of the most prominent approaches of emotion regulation is reappraisal . Reappraisal has been shown to consistently activate cognitive control regions and to modulate the bilateral amygdala. Insufficient prefrontal control and reduced downregulation of those prefrontal regions of the amygdala while reappraising negative stimuli has been consistently found in bipolar disorder.
Methods:
Using a double-blind, parallel-group design, 37 healthy volunteers (male and female) are randomly allocated to a 11 (+/- 1) day lithium administration or a placebo condition. After the intervention period, all participants undergo fMRI testing with the MID task and the emotional suppression task to assess reward processing and reappraisal of negative stimuli. The participants also complete a visual control task (checkerboard task) and several behavioural tasks and questionnaires. Lithium levels are measured at the end of the intervention period.
Hypothesis:
Based on the literature on bipolar disorder and the mood stabilising effects of Lithium, the investigators expect lithium administration in healthy participants to:
- Increase caudate activity during reward anticipation
- Increase activation of prefrontal control regions as well as increase negative connectivity between those regions and the amygdala during reappraisal
Fidelity check: significant increases in lithium levels in the lithium intervention group compared to the placebo group.
- Conditions
- Healthy
- Being tested
- Lithium, Placebo - Rayotabs
- Keywords
- Lithium, Reward, Caudate, Reappraisal, Prefrontal cortex, Amygdala
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Also called Priadel, Lithium carbonate
Placebo - RayotabsOther
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | Increasing amounts of lithium for 11 plus or minus 1 day. Day 1: 400 mg at night Day 2: 600 mg at night Day 3-11: 800 mg at night. The lithium intervention was prepared from 200mg Priadel prolonged release tablets. The intervention was provided in blue and white gelatine capsules to be taken orally. Receives: Drug: Lithium |
| Rayotabs | Placebo comparator | The placebo intervention was 200mg Rayotabs. The intervention was provided in blue and white gelatine capsules to be taken orally - same as the lithium intervention to maintain blinding. Receives: Other: Placebo - Rayotabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain response to reward anticipation (MID task, Knutson et al. 2001)
Participants are presented with a cue indicating the option to get a reward when responding correctly, no reward when responding correctly, or a cue indicating not to move, while laying in the MR scanner (fMRI study). Group differences in the brain response while anticipating a reward (after reward cue) will be compared to the brain response while not anticipating a reward (after no reward cue). The tested region of brain activation will be restricted to the caudate nucleus and the nucleus accumbens, based on Yip et al. (2015) and Knutson et al. (2001).
Measured: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).
Brain response during reappraisal task (Phan et al. 2005)
Participants will perform a reappraisal task (Phan et al. 2005). Trials in which they were asked to either down-regulate negative affect evoked by highly arousing and aversive pictures (e.g., experience naturally) using cognitive reappraisal will be compared to trials where negative affect if maintained. Group differences in brain activation changes during this comparison will be assessed with a specific focus on the prefrontal cortex, as well as on connectivity changes between prefrontal cortex and amygdala during this contrast.
Measured: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).
Secondary outcomes (1)
brain activation in response to reward feedback (MID task)
Participants are presented with a cue indicating the option to get a reward when responding correctly, no reward when responding correctly, or a cue indicating not to move, while laying in the MR scanner (fMRI study). After an inter-trial-interfval of 2000-2500ms, a target is presented during which participants need to press a button on reward and no reward trials. If they respond on time it is a hit, otherwise a loss. Group differences in the brain response while receiving feedback on a hit during reward trials will be compared to the brain response while receiving feedback on a loss during reward trials. The tested region of brain activation will be restricted to the caudate nucleus and the nucleus accumbens, based on Yip et al. (2015) and Knutson et al. (2001).
Measured: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start31 Oct 2011
- Primary completion4 Sep 2012
- Study completion4 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to the placebo or lithium group. The two groups were matched in terms of age and gender.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CatherineHarmer, University of Oxford
- Investigators
- Catherine Harmer, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965247
- Sponsor's protocol ID
- REC 10/H0605/71
- Status last verified
- May 2019
- First submitted
- 26 Apr 2019
- Last updated
- 28 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When data was collected, no approval was acquired to share individual participant data. The investigators will make the summary statistics and analyses scripts available.
Publications
Yip SW, Worhunsky PD, Rogers RD, Goodwin GM. Hypoactivation of the ventral and dorsal striatum during reward and loss anticipation in antipsychotic and mood stabilizer-naive bipolar disorder. Neuropsychopharmacology. 2015 Feb;40(3):658-66. doi: 10.1038/npp.2014.215. Epub 2014 Aug 13.
PubMed 25139065Lahteenvuo M, Tanskanen A, Taipale H, Hoti F, Vattulainen P, Vieta E, Tiihonen J. Real-world Effectiveness of Pharmacologic Treatments for the Prevention of Rehospitalization in a Finnish Nationwide Cohort of Patients With Bipolar Disorder. JAMA Psychiatry. 2018 Apr 1;75(4):347-355. doi: 10.1001/jamapsychiatry.2017.4711.
PubMed 29490359Knutson B, Fong GW, Adams CM, Varner JL, Hommer D. Dissociation of reward anticipation and outcome with event-related fMRI. Neuroreport. 2001 Dec 4;12(17):3683-7. doi: 10.1097/00001756-200112040-00016.
PubMed 11726774Oldham S, Murawski C, Fornito A, Youssef G, Yucel M, Lorenzetti V. The anticipation and outcome phases of reward and loss processing: A neuroimaging meta-analysis of the monetary incentive delay task. Hum Brain Mapp. 2018 Aug;39(8):3398-3418. doi: 10.1002/hbm.24184. Epub 2018 Apr 25.
PubMed 29696725Buhle JT, Silvers JA, Wager TD, Lopez R, Onyemekwu C, Kober H, Weber J, Ochsner KN. Cognitive reappraisal of emotion: a meta-analysis of human neuroimaging studies. Cereb Cortex. 2014 Nov;24(11):2981-90. doi: 10.1093/cercor/bht154. Epub 2013 Jun 13.
PubMed 23765157Townsend JD, Torrisi SJ, Lieberman MD, Sugar CA, Bookheimer SY, Altshuler LL. Frontal-amygdala connectivity alterations during emotion downregulation in bipolar I disorder. Biol Psychiatry. 2013 Jan 15;73(2):127-35. doi: 10.1016/j.biopsych.2012.06.030. Epub 2012 Aug 1.
PubMed 22858151Kanske P, Schonfelder S, Forneck J, Wessa M. Impaired regulation of emotion: neural correlates of reappraisal and distraction in bipolar disorder and unaffected relatives. Transl Psychiatry. 2015 Jan 20;5(1):e497. doi: 10.1038/tp.2014.137.
PubMed 25603413Zhang L, Opmeer EM, van der Meer L, Aleman A, Curcic-Blake B, Ruhe HG. Altered frontal-amygdala effective connectivity during effortful emotion regulation in bipolar disorder. Bipolar Disord. 2018 Jun;20(4):349-358. doi: 10.1111/bdi.12611. Epub 2018 Feb 11.
PubMed 29430790Hirschowitz J, Kolevzon A, Garakani A. The pharmacological treatment of bipolar disorder: the question of modern advances. Harv Rev Psychiatry. 2010 Sep-Oct;18(5):266-78. doi: 10.3109/10673229.2010.507042.
PubMed 20825264Phan KL, Fitzgerald DA, Nathan PJ, Moore GJ, Uhde TW, Tancer ME. Neural substrates for voluntary suppression of negative affect: a functional magnetic resonance imaging study. Biol Psychiatry. 2005 Feb 1;57(3):210-9. doi: 10.1016/j.biopsych.2004.10.030.
PubMed 15691521
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-term Lithium Administration on Striatal Reward Processing and Prefrontal Control During Reappraisal in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03965247
- Acronym / sponsor ID
- REC 10/H0605/71
- Conditions
- Healthy
- Keywords
- Lithium, Reward, Caudate, Reappraisal, Prefrontal cortex, Amygdala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 31 Oct 2011 (actual)
- Primary completion
- 4 Sep 2012 (actual)
- Study completion
- 4 Sep 2012 (actual)
- First posted
- 28 May 2019 (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.
Bipolar disorder has been associated with blunted activity in regions associated with emotional processing, such as striatal activity during reward anticipation as well as prefrontal activity during reappraisal. Lithium is the most effective treatment in bipolar disorder. Neurochemical and molecular basis of lithium is well known, but how this translates to mood stabilisation is not understood. This study is designed to address how lithium influences reward and emotion regulation processes in humans.
Detailed description
Background:
Bipolar disorder is a relatively common psychiatric disorder for which treatment options are limited. The so-called mood stabiliser, lithium (usually in the form of lithium carbonate) is one of the most commonly used treatments for the disorder, and is effective in treating both acute mania and as a long term maintenance treatment. The investigator's understanding of the pharmacological mechanisms by which lithium exerts its actions is fairly well developed, however there is a lack of understanding of the psychological mechanisms. Within this study the investigators will look at two different types of emotional processing, namely reward anticipation/feedback and emotion regulation, to gain more understanding on how lithium exerts its mood stabilising effects.
Reward processing:
The neural correlates underlying reward anticipation and feedback can be measured with the Monetary Incentive Delay (MID) task, a widely used task for different disorders. Reward anticipation during the MID task has been associated among others, with ventral and dorsal striatum activity. Most critically, bipolar disorder has been associated with blunted reward function of the medial caudate. Reward feedback has been associated with ventral striatum and OFC/vmPFC activity.
Emotion regulation:
One of the most prominent approaches of emotion regulation is reappraisal . Reappraisal has been shown to consistently activate cognitive control regions and to modulate the bilateral amygdala. Insufficient prefrontal control and reduced downregulation of those prefrontal regions of the amygdala while reappraising negative stimuli has been consistently found in bipolar disorder.
Methods:
Using a double-blind, parallel-group design, 37 healthy volunteers (male and female) are randomly allocated to a 11 (+/- 1) day lithium administration or a placebo condition. After the intervention period, all participants undergo fMRI testing with the MID task and the emotional suppression task to assess reward processing and reappraisal of negative stimuli. The participants also complete a visual control task (checkerboard task) and several behavioural tasks and questionnaires. Lithium levels are measured at the end of the intervention period.
Hypothesis:
Based on the literature on bipolar disorder and the mood stabilising effects of Lithium, the investigators expect lithium administration in healthy participants to:
- Increase caudate activity during reward anticipation
- Increase activation of prefrontal control regions as well as increase negative connectivity between those regions and the amygdala during reappraisal
Fidelity check: significant increases in lithium levels in the lithium intervention group compared to the placebo group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to the placebo or lithium group. The two groups were matched in terms of age and gender.
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: LithiumIncreasing amounts of lithium for 11 plus or minus 1 day. Day 1: 400 mg at night Day 2: 600 mg at night Day 3-11: 800 mg at night. The lithium intervention was prepared from 200mg Priadel prolonged release tablets. The intervention was provided in blue and white gelatine capsules to be taken orally. |
| Rayotabs | Placebo comparator | Other: Placebo - RayotabsThe placebo intervention was 200mg Rayotabs. The intervention was provided in blue and white gelatine capsules to be taken orally - same as the lithium intervention to maintain blinding. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is willing and able to give informed consent for participation in the study.
- Subject is between 18 and 55 years of age
- Subject has a body mass index (BMI) in the range of 19-30
- Subjects will be physically fit, as assessed by a physical examination by a medical doctor.
- if female and of child bearing age must have a negative pregnancy test for inclusion and must be using two forms of effective contraception.
Key exclusion criteria (10 listed)
- taking psychotropic medication
- any past or current axis 1 psychiatric disorder on DSM-IV
- Any medical contra-indication (for example, conditions that might alter absorption of lithium or which could impact on the safety of the druk for the volunteer, for example impaired renal function as assessed by creatinine levels or impaired thyroid function as assessed by thyroid stimulating hormone levels)
- Current pregnancy or breastfeeding
- Current or past history of drug or alcohol dependency
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 |
|---|---|---|
| LithiumAlso: Priadel, Lithium carbonate | Drug | Lithium |
| Placebo - Rayotabs | Other | Rayotabs |
Primary outcome
brain response to reward anticipation (MID task, Knutson et al. 2001)
Time frame: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).
Participants are presented with a cue indicating the option to get a reward when responding correctly, no reward when responding correctly, or a cue indicating not to move, while laying in the MR scanner (fMRI study). Group differences in the brain response while anticipating a reward (after reward cue) will be compared to the brain response while not anticipating a reward (after no reward cue). The tested region of brain activation will be restricted to the caudate nucleus and the nucleus accumbens, based on Yip et al. (2015) and Knutson et al. (2001).
Brain response during reappraisal task (Phan et al. 2005)
Time frame: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).
Participants will perform a reappraisal task (Phan et al. 2005). Trials in which they were asked to either down-regulate negative affect evoked by highly arousing and aversive pictures (e.g., experience naturally) using cognitive reappraisal will be compared to trials where negative affect if maintained. Group differences in brain activation changes during this comparison will be assessed with a specific focus on the prefrontal cortex, as well as on connectivity changes between prefrontal cortex and amygdala during this contrast.
1 secondary outcome
brain activation in response to reward feedback (MID task)
Time frame: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).
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 28 May 2019.
- Background: PubMed 25139065Yip SW, Worhunsky PD, Rogers RD, Goodwin GM. Hypoactivation of the ventral and dorsal striatum during reward and loss anticipation in antipsychotic and mood stabilizer-naive bipolar disorder. Neuropsychopharmacology. 2015 Feb;40(3):658-66. doi: 10.1038/npp.2014.215. Epub 2014 Aug 13.
- Background: PubMed 29490359Lahteenvuo M, Tanskanen A, Taipale H, Hoti F, Vattulainen P, Vieta E, Tiihonen J. Real-world Effectiveness of Pharmacologic Treatments for the Prevention of Rehospitalization in a Finnish Nationwide Cohort of Patients With Bipolar Disorder. JAMA Psychiatry. 2018 Apr 1;75(4):347-355. doi: 10.1001/jamapsychiatry.2017.4711.
- Background: PubMed 11726774Knutson B, Fong GW, Adams CM, Varner JL, Hommer D. Dissociation of reward anticipation and outcome with event-related fMRI. Neuroreport. 2001 Dec 4;12(17):3683-7. doi: 10.1097/00001756-200112040-00016.
- Background: PubMed 29696725Oldham S, Murawski C, Fornito A, Youssef G, Yucel M, Lorenzetti V. The anticipation and outcome phases of reward and loss processing: A neuroimaging meta-analysis of the monetary incentive delay task. Hum Brain Mapp. 2018 Aug;39(8):3398-3418. doi: 10.1002/hbm.24184. Epub 2018 Apr 25.
- Background: PubMed 23765157Buhle JT, Silvers JA, Wager TD, Lopez R, Onyemekwu C, Kober H, Weber J, Ochsner KN. Cognitive reappraisal of emotion: a meta-analysis of human neuroimaging studies. Cereb Cortex. 2014 Nov;24(11):2981-90. doi: 10.1093/cercor/bht154. Epub 2013 Jun 13.
- Background: PubMed 22858151Townsend JD, Torrisi SJ, Lieberman MD, Sugar CA, Bookheimer SY, Altshuler LL. Frontal-amygdala connectivity alterations during emotion downregulation in bipolar I disorder. Biol Psychiatry. 2013 Jan 15;73(2):127-35. doi: 10.1016/j.biopsych.2012.06.030. Epub 2012 Aug 1.
- Background: PubMed 25603413Kanske P, Schonfelder S, Forneck J, Wessa M. Impaired regulation of emotion: neural correlates of reappraisal and distraction in bipolar disorder and unaffected relatives. Transl Psychiatry. 2015 Jan 20;5(1):e497. doi: 10.1038/tp.2014.137.
- Background: PubMed 29430790Zhang L, Opmeer EM, van der Meer L, Aleman A, Curcic-Blake B, Ruhe HG. Altered frontal-amygdala effective connectivity during effortful emotion regulation in bipolar disorder. Bipolar Disord. 2018 Jun;20(4):349-358. doi: 10.1111/bdi.12611. Epub 2018 Feb 11.
- Background: PubMed 20825264Hirschowitz J, Kolevzon A, Garakani A. The pharmacological treatment of bipolar disorder: the question of modern advances. Harv Rev Psychiatry. 2010 Sep-Oct;18(5):266-78. doi: 10.3109/10673229.2010.507042.
- Background: PubMed 15691521Phan KL, Fitzgerald DA, Nathan PJ, Moore GJ, Uhde TW, Tancer ME. Neural substrates for voluntary suppression of negative affect: a functional magnetic resonance imaging study. Biol Psychiatry. 2005 Feb 1;57(3):210-9. doi: 10.1016/j.biopsych.2004.10.030.
- Individual participant dataSharing planned: No. When data was collected, no approval was acquired to share individual participant data. The investigators will make the summary statistics and analyses scripts available.
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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.
Catherine Harmer principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
A study testing Lithium in people with Healthy, run by University of Oxford.
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 9 inclusion and 10 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
brain response to reward anticipation (MID task, Knutson et al. 2001) (time frame: Completed during the final day of the intervention period (day 11 (+/- 1) of lithium or placebo treatment).). The study lists 2 primary outcomes in all. 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 NCT03965247, which also lists 10 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 28 May 2019.