DepressionNCT02189915
Open-Label Creatine Study for Female Meth Users
A study testing Creatine monohydrate in people with Depression and Dual Diagnosis, run by Perry Renshaw at 1 site in United States.
Trial summary
Study Purposes and Objectives: The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language. Read more about this study
- Who is it for?
- Ages 13 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Dual Diagnosis, Substance Use
- What is being tested?
- Creatine monohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2015
- Phase
- Interventional
- 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 13 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must be female
- Must be between the ages of 13 and 55 years
- Methamphetamine must be primary drug of choice
- Must have used methamphetamine within the last 6 months
- For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17
- For participants < 18 years of age, must have a Children Depression Rating Scale (CDRS) score of > 40
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- Must be able to give informed consent
- Must be female
- Must be between the ages of 13 and 55 years
- Must be able to give informed consent
Who cannot join
- Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
- DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- Known pregnancy or positive urine HCG test
- Current serious homicidal or suicidal risk
- Young Mania Rating Scale (YMRS) score > 7
- Inability to comply with the protocol
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- Contraindication to an MR scan
- Positive HIV test
- Known sensitivity to creatine monohydrate
- Significant current medical illness
- DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary psychotic symptoms, substance use disorders, and anxiety disorders)
- Known pregnancy or positive urine HCG test
- Contraindication to an MR scan
- Inability to comply with the protocol
- Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
Study Purposes and Objectives:
The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language.
Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.
- Conditions
- Depression, Dual Diagnosis, Substance Use
- Being tested
- Creatine monohydrate
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | Not described Receives: Drug: Creatine monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Rating Scores
Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.
Measured: 8-week
Secondary outcomes (1)
Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy
Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJan 2012
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Received funding for the next phase of the study
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perry Renshaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Perry Renshaw, University of Utah
- Investigators
- Perry Renshaw, MD, PhD, MBA, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189915
- Sponsor's protocol ID
- 53737
- Status last verified
- Apr 2016
- First submitted
- 11 Jul 2014
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
- ClinicalTrials.gov ID
- NCT02189915
- Acronym / sponsor ID
- 53737
- Conditions
- Depression, Dual Diagnosis, Substance Use
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Received funding for the next phase of the study
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Perry RenshawUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 20 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Purposes and Objectives:
The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language.
Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.
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 monohydrate |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Must be female
- Must be between the ages of 13 and 55 years
- Methamphetamine must be primary drug of choice
- Must have used methamphetamine within the last 6 months
- For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17
Key exclusion criteria (15 listed)
- Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
- DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- Known pregnancy or positive urine HCG test
- Current serious homicidal or suicidal risk
- Young Mania Rating Scale (YMRS) score > 7
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 monohydrate | Drug | Creatine monohydrate |
Primary outcome
Depression Rating Scores
Time frame: 8-week
Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.
1 secondary outcome
Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Perry Renshaw, MD, PhD, MBA principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate in people with Depression and Dual Diagnosis, run by Perry Renshaw 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 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2016). 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?
Depression Rating Scores (time frame: 8-week). 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 20 May 2016.