Major Depressive DisorderEarly Phase 1NCT01601210
Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
A Early Phase 1 study of Major Depressive Disorder, run by Perry Renshaw at 1 site in United States.
Trial summary
The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Read more about this study
- Who is it for?
- Ages 13 to 21 years, women only
- Conditions the study is for
- Major Depressive Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2014
- Phase
- Early Phase 1
- 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 13 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must be female.
- Participants must be able to grant informed consent (age > 18), or parent/guardian permission plus participant assent (age < 18).
- Participants must meet DSM-IV criteria for MDD, with current mood state depressed for > 2 weeks.
- Participants must be between the ages of 13 and 21.
- Current CDRS-R raw score of > 40 or MADRS score > 25; and CGI-S score > 4.
- Participants may be enrolled in individual and/or group psychotherapy, if it has been ongoing for at least 8 weeks.
- Participants must have been in treatment with an SSRI for at least 8 weeks, the last 4 of which were at a dosage of > or equal to 20 mg per day of fluoxetine or its equivalent, e.g. 20 mg per day of paroxetine, 20 mg citalopram, 10 mg escitalopram, or 100 mg sertraline. If the participant attempted, but could not tolerate, a dose comparable to 20 mg fluoxetine, they will be considered eligible.
Who cannot join
- Unstable co-morbid medical, neurological, or psychiatric disorder.
- Current DSM-IV criteria for substance abuse or dependence (excepting nicotine/cigarettes).
- Clinically significant suicidal or homicidal risk.
- Pre-existing renal disease.
- Proteinuria on baseline urinalysis testing.
- Treatment with antiepileptic drugs, antipsychotic drugs, or lithium.
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- Pregnancy or breastfeeding.
- Sexually active and unwilling to practice contraception during the study.
- Contraindication to magnetic resonance imaging (e.g. ferromagnetic implant or claustrophobia)
- History of hypersensitivity to creatine.
- History of a previous failed therapeutic trial of creatine.
- Participants may be outpatients or inpatients, but incarcerated persons will be excluded because this study is not approved for "Research Involving Prisoners."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.
The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.
Read the detailed description
The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Creatine may have effects of interest in the brain. The reason for the MRI component of this study is to learn about new ways to see inside the brain. The investigators will use magnetic fields and radio waves to look at the brain and chemicals in the brain. The investigators hope that this technique will have medial use in the future.
The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations. A secondary hypothesis is that decreased depressive symptoms measured with the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.
- Conditions
- Major Depressive Disorder
- Being tested
- Creatine monohydrate or placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrate or placeboDrug
Placebo, 2g, 4g, and 10g of creatine monohydrate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Creatine monohydrate or placebo |
| 2 grams of creatine | Active comparator | Not described Receives: Drug: Creatine monohydrate or placebo |
| 4 grams of creatine | Active comparator | Not described Receives: Drug: Creatine monohydrate or placebo |
| 10 grams of creatine | Active comparator | Not described Receives: Drug: Creatine monohydrate or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain PCr concentrations
The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.
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 posted17 May 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- Douglas Kondo, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601210
- Sponsor's protocol ID
- 00055231
- Status last verified
- Oct 2016
- First submitted
- 17 Apr 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
- ClinicalTrials.gov ID
- NCT01601210
- Acronym / sponsor ID
- 00055231
- Conditions
- Major Depressive Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Perry RenshawUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 May 2012 (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.
The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers.
The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.
Detailed description
The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Creatine may have effects of interest in the brain. The reason for the MRI component of this study is to learn about new ways to see inside the brain. The investigators will use magnetic fields and radio waves to look at the brain and chemicals in the brain. The investigators hope that this technique will have medial use in the future.
The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations. A secondary hypothesis is that decreased depressive symptoms measured with the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Creatine monohydrate or placebo |
| 2 grams of creatine | Active comparator | Drug: Creatine monohydrate or placebo |
| 4 grams of creatine | Active comparator | Drug: Creatine monohydrate or placebo |
| 10 grams of creatine | Active comparator | Drug: Creatine monohydrate or placebo |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Participants must be female.
- Participants must be able to grant informed consent (age > 18), or parent/guardian permission plus participant assent (age < 18).
- Participants must meet DSM-IV criteria for MDD, with current mood state depressed for > 2 weeks.
- Participants must be between the ages of 13 and 21.
- Current CDRS-R raw score of > 40 or MADRS score > 25; and CGI-S score > 4.
Key exclusion criteria (12 listed)
- Unstable co-morbid medical, neurological, or psychiatric disorder.
- Current DSM-IV criteria for substance abuse or dependence (excepting nicotine/cigarettes).
- Clinically significant suicidal or homicidal risk.
- Pre-existing renal disease.
- Proteinuria on baseline urinalysis testing.
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 or placeboPlacebo, 2g, 4g, and 10g of creatine monohydrate | Drug | 10 grams of creatine, 2 grams of creatine, 4 grams of creatine, Placebo |
Primary outcome
Brain PCr concentrations
Time frame: 8 weeks
The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.
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 25 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Douglas Kondo, MD 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 Early Phase 1 study of Major Depressive Disorder, 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 7 inclusion and 12 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 25 Oct 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Brain PCr concentrations (time frame: 8 weeks). 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 25 Oct 2016.