<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02189915</url>
  </required_header>
  <id_info>
    <org_study_id>53737</org_study_id>
    <nct_id>NCT02189915</nct_id>
  </id_info>
  <brief_title>Open-Label Creatine Study for Female Meth Users</brief_title>
  <official_title>Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Perry Renshaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Purposes and Objectives:&#xD;
&#xD;
      The objectives should be stated in such a way that the reader can determine the&#xD;
      appropriateness of the study design. If appropriate, state the specific hypotheses being&#xD;
      tested and/or study aims. Use lay language.&#xD;
&#xD;
      Methamphetamine use is of great concern in the state of Utah because it's the primary drug of&#xD;
      threat in the state, and is the primary drug of choice among females between the ages of 18&#xD;
      and 24. The primary hypothesis of the study is that eight weeks of oral creatine&#xD;
      supplementation will result in improvements in depression rating scores in female MA users.&#xD;
      Secondary hypotheses include the following: 1) creatine supplementation will result in a&#xD;
      decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase&#xD;
      after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal&#xD;
      lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral&#xD;
      supplementation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Received funding for the next phase of the study&#xD;
  </why_stopped>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression Rating Scores</measure>
    <time_frame>8-week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy</measure>
    <time_frame>8 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Depression</condition>
  <condition>Dual Diagnosis</condition>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Creatine monohydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Creatine monohydrate</intervention_name>
    <arm_group_label>Creatine monohydrate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be female&#xD;
&#xD;
          2. Must be between the ages of 13 and 55 years&#xD;
&#xD;
          3. Methamphetamine must be primary drug of choice&#xD;
&#xD;
          4. Must have used methamphetamine within the last 6 months&#xD;
&#xD;
          5. For participants &gt; 18 years of age, must have a Hamilton Depression Rating Scale (HDRS&#xD;
             or HAM-D) score of &gt; 17&#xD;
&#xD;
          6. For participants &lt; 18 years of age, must have a Children Depression Rating Scale&#xD;
             (CDRS) score of &gt; 40&#xD;
&#xD;
          7. Must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant current or past medical conditions, such as cardiovascular, renal or&#xD;
             endocrine disorders&#xD;
&#xD;
          2. DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder&#xD;
&#xD;
          3. Known pregnancy or positive urine HCG test&#xD;
&#xD;
          4. Current serious homicidal or suicidal risk&#xD;
&#xD;
          5. Young Mania Rating Scale (YMRS) score &gt; 7&#xD;
&#xD;
          6. Inability to comply with the protocol&#xD;
&#xD;
          7. Contraindication to an MR scan&#xD;
&#xD;
          8. Positive HIV test&#xD;
&#xD;
          9. Known sensitivity to creatine monohydrate&#xD;
&#xD;
        Inclusion criteria for healthy comparison group:&#xD;
&#xD;
          1. Must be female&#xD;
&#xD;
          2. Must be between the ages of 13 and 55 years&#xD;
&#xD;
          3. Must be able to give informed consent&#xD;
&#xD;
        Exclusion criteria for healthy comparison group:&#xD;
&#xD;
          1. Significant current medical illness&#xD;
&#xD;
          2. DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS,&#xD;
             major depressive disorder, dysthymia disorder, depressive disorder NOS, primary&#xD;
             psychotic symptoms, substance use disorders, and anxiety disorders)&#xD;
&#xD;
          3. Known pregnancy or positive urine HCG test&#xD;
&#xD;
          4. Contraindication to an MR scan&#xD;
&#xD;
          5. Inability to comply with the protocol&#xD;
&#xD;
          6. Positive urine drug screen (unless it is positive for a low dose prescription opiate&#xD;
             that is taken as prescribed)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Perry Renshaw, MD, PhD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>February 16, 2016</results_first_submitted>
  <results_first_submitted_qc>April 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 20, 2016</results_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Perry Renshaw</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Creatine Monohydrate Treatment</title>
          <description>This study is an open label study, where all participants received Creatine monohydrate.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Creatine Monohydrate</title>
          <description>Creatine monohydrate</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.4" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depression Rating Scores</title>
        <description>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.</description>
        <time_frame>8-week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Creatine Monohydrate Treatment</title>
            <description>This study is an open label study, where all participants received Creatine monohydrate.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Rating Scores</title>
          <description>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.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.86" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 8 weeks of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.36" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy</title>
        <description>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.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Creatine Monohydrate Treatment</title>
            <description>This study is an open label study, where all participants received Creatine monohydrate.</description>
          </group>
        </group_list>
        <measure>
          <title>Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy</title>
          <description>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.</description>
          <units>Phosphocreatine levels (unitless)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.223" spread="0.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.233" spread="0.009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Creatine Monohydrate Treatment</title>
          <description>This study is an open label study, where all participants received Creatine monohydrate.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurry vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Indigestion, Nausea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Swelling in hands</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Numbness, tingling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Perry Renshaw, MD, PhD, MBA</name_or_title>
      <organization>The Brain Institute of the University of Utah</organization>
      <phone>801-587-1216</phone>
      <email>perry.renshaw@hsc.utah.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189915
org study id: 53737
nct id: NCT02189915
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Depression Rating Scores
time frame: 8-week
description: 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.
measure: Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy
time frame: 8 weeks
description: 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.
arm group label: Creatine monohydrate
arm group type: Experimental
intervention type: Drug
intervention name: Creatine monohydrate
arm group label: Creatine monohydrate
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Perry Renshaw, MD, PhD, MBA
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Utah
investigator full name: Perry Renshaw
investigator title: Professor of Psychiatry
mesh term: Substance-Related Disorders
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 