DepressionPhase 3NCT02568878
Creatine for Depressed Male and Female Methamphetamine Users
A Phase 3 study testing Creatine monohydrate in people with Depression and Anxiety, run by Montana State University at 1 site in United States.
Trial summary
Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users Assess creatine's effect on methamphetamine use Assess the safety of creatine in male methamphetamine users with depression Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Depression, Anxiety, Methamphetamine Dependence
- What is being tested?
- Creatine monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to May 2017
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse
- Current diagnosis of major depressive disorder (primary or substance-induced)
- Current diagnosis of an anxiety disorder (primary or substance-induced)
- Current Hamilton Depression Rating scale score > or = to 16
- Current Hamilton Anxiety Scale score > = to 18
- If taking a psychotropic medication for depressed or anxious mood, regimen must be stable for > = to 4 weeks prior to creatine treatment initiation
Who cannot join
- Persons unable to provide adequate informed consent
- Persons who are at clinically significant suicidal or homicidal risk
- Primary substance-related diagnosis other than methamphetamine dependence or abuse
- Positive pregnancy test (females only)
- History of renal disease
- Clinically significant medical or neurological illness identified by history, physical exam and laboratory testing
- History of hypersensitivity reaction to creatine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montana State University College of Nursing (Missoula campus)
Missoula, Montana, 59812
Tracy Hellem, PhD, 406-243-2110, tracy.Hellem1@montana.edu
4062432110
About this study
Official title: An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
- Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users
- Assess creatine's effect on methamphetamine use
- Assess the safety of creatine in male methamphetamine users with depression
- Conditions
- Depression, Anxiety, Methamphetamine Dependence
- Being tested
- Creatine monohydrate
- Keywords
- Depression, Anxiety, Methamphetamine dependence
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDrug
Also called Creapure
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | 5 grams of daily creatine monohydrate by mouth for 8 weeks Receives: Drug: Creatine monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAMD) Scores
Measured: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Hamilton Anxiety Rating Scale (HAMA) Scores
Measured: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Secondary outcomes (3)
Self-reported methamphetamine use
Measured: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Incidence of treatment-emergent adverse events
Measured: Adverse events will be reviewed monthly for safety concerns and presented at study completed (anticipated: 12 months after study initiation).
Percent of positive urine drug screens for methamphetamine
Measured: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Hellem, Montana State University
- Investigators
- Tracy Hellem, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568878
- Sponsor's protocol ID
- 01
- Status last verified
- Dec 2015
- First submitted
- 1 Oct 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
- ClinicalTrials.gov ID
- NCT02568878
- Acronym / sponsor ID
- 01
- Conditions
- Depression, Anxiety, Methamphetamine Dependence
- Keywords
- Depression, Anxiety, Methamphetamine dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 6 Oct 2015 (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.
- Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users
- Assess creatine's effect on methamphetamine use
- Assess the safety of creatine in male methamphetamine users with depression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Creatine monohydrate | Experimental | Drug: Creatine monohydrate5 grams of daily creatine monohydrate by mouth for 8 weeks |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse
- Current diagnosis of major depressive disorder (primary or substance-induced)
- Current diagnosis of an anxiety disorder (primary or substance-induced)
- Current Hamilton Depression Rating scale score > or = to 16
- Current Hamilton Anxiety Scale score > = to 18
Key exclusion criteria (7 listed)
- Persons unable to provide adequate informed consent
- Persons who are at clinically significant suicidal or homicidal risk
- Primary substance-related diagnosis other than methamphetamine dependence or abuse
- Positive pregnancy test (females only)
- History of renal 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 |
|---|---|---|
| Creatine monohydrateAlso: Creapure | Drug | Creatine monohydrate |
Primary outcome
Hamilton Depression Rating Scale (HAMD) Scores
Time frame: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Hamilton Anxiety Rating Scale (HAMA) Scores
Time frame: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
3 secondary outcomes
Self-reported methamphetamine use
Time frame: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Incidence of treatment-emergent adverse events
Time frame: Adverse events will be reviewed monthly for safety concerns and presented at study completed (anticipated: 12 months after study initiation).
Percent of positive urine drug screens for methamphetamine
Time frame: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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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.
Tracy Hellem, PhD principal investigator
Montana State University
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 Creatine monohydrate in people with Depression and Anxiety, run by Montana State University 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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2015. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Hellem, PhD (406 243 2110, tracy.hellem1@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAMD) Scores (time frame: This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).). 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?
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 11 Dec 2015.