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Clinical Trials Registry, UHRSDA

Please note: We at UHRSDA do not run clinical trials in pharmaceuticals. We support research in nutraceuticals, behavior interventions, exercise, diet, yoga, psychotherapy, counseling, and others.

Creatine Monohydrate has been proposed as an augmentation strategy for treating depression; however, its efficacy in the absence of antidepressants along with psychotherapy alone is limited. This study, which is the first of its kind double-blind, parallel arm, randomized placebo control pilot trial, investigated the antidepressant effect of Creatine Monohydrate when administered with cognitive behavioral therapy in people suffering from Major Depressive Disorder

Study Description                                     Ref no:  ECR/4263/MH/UK/2020/RR-21
Brief Summary:  

 Condition or disease                                                     Intervention/ treatment                                                   Phase

 

 MDD (Depression)                                                                  Drug: Creatine Monohydrate                                                    Phase 2 (Nutraceuticals)                                                                                                                                  Procedure: PHQ-9 Rating Scale

                                                                                                    Drug: Placebo (Starch)                                                                          

                                                                                                                     

Arms and Interventions

Aim                                                                                                                                                                   Intervention/ Treatment

Experimental: Creatine Monohydrate                                                                                                                     Drug: Creatine Monohydrate

-Creatine monohydrate 5 g per day for 8 weeks + Cognitive Behavioral therapy (CBT)                                  Procedure: PHQ-9 Rating Scale to assess level of Depression (MDD) during screening.

   during each screening.                                                                                                                                        - N= 15 Men, N= 15 female

                                                                                                                                                                                    - Screening: Baseline, Week 2, Week 4, Week 6, Week 8

                                                                                                                                                                                    - Administering Creatine 5g everyday and CBT during screening days.

 

Sham: Placebo (Starch)                                                                                                                                         Drug: Placebo (Starch)

-Placebo  5 g per day for 8 weeks + Cognitive Behavioral therapy (CBT) during each screening.                Procedure: PHQ-9 Rating Scale to assess level of Depression (MDD) during screening.

                                                                                                                                                                                    - N= 15 Men, N= 15 female

                                                                                                                                                                                    - Screening: Baseline, Week 2, Week 4, Week 6, Week 8

                                                                                                                                                                                    - Administering Placebo 5g everyday and CBT during screening days.

Study Design

Study Type:    Interventional  (Clinical Trial)
Actual Enrollment:    60 participants (N=30 men, N= 30 female)
Allocation:    Randomized

Intervention Model:    Parallel arm assignment
Masking:    Double (Participant, Investigator)
Masking Description:   Blocks of 10 patients (Equal ratio sex-wise) will be used to allocate patients to Creatine  Monohydrate or placebo.
Primary Purpose:    Treatment
Official Title:  Effects of Oral Creatine Monohydrate in people suffering from Depression: A double-blind, randomized, placebo-controlled pilot trial.
Actual Study Start Date:    November 22, 2020
Actual Primary Completion Date:    June 6, 2022
Actual Study Completion Date:    (Ongoing)

Outcome Measures

Primary Outcome Measures:

     - measure the antidepressant effect between creatine and placebo arm. [ Time Frame: Through 8 weeks ]

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Secondary Outcome Measures

    - association between BMI and MDD [ Time Frame: Through 8 weeks ].

    - association between sex differences and MDD [ Time Frame: Through 8 weeks ].

    - association between side effects and treatment arm  [ Time Frame: Through 8 weeks ].

Eligibility Criteria

Ages Eligible for Study:  18 Years and older  till 59 years  (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

 

Criteria

    - Inclusion Criteria

               - A board certified clinical psychologist's diagnosis of depression, as defined by the DSM-5 and ICD 10.

              - At least 18 years of age and not exceeding 59 years at the time of study registration.

              - At least 5 or above score in PHQ=9 questionnaire.

              - Able to understand and willing to sign an approved written informed consent document (or that of legally authorized representative, if applicable).

               -  Male patients if engaging in sex with a women of childbearing potential are required to use two forms of acceptable contraception, including one                          barrier method, during participation in the study and throughout the evaluation period.

               - Women of childbearing potential (defined as women with regular menses, women with amenorrhea and  women with irregular cycles) are required                       to have a negative pregnancy test and use only one form of acceptable contraception which is barrier method, during participation in the study                             treatment period.

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   - Exclusion Criteria

               - known allergy or intolerance to creatine or starch.

               - pregnant or breastfeeding female.

              -  history of alcohol or other substance misuse.

              -  any clinically significant medical or mental disorder other than depression.

              -  no psychotropic drugs used for at least eight weeks before the screening evaluation. 

Contacts and Locations

Location

    -  India, Dehradun

               UHRSDA Clinic, Dehradun 

                241- Vijay Park, India. 248001.

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Sponsors and Collaborators

   - UHRSDA Non for Profit Organisation (License No: 06008112018333622 )

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Investigators

   - Principal Investigator: Nima Norbu Sherpa, Research Psychologist. UHRSDA Junior Fellow in Mental Health

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More Information

 

   Responsible Party:    UHRSDA;  Non for Profit Organisation (License No: 06008112018333622 )
   UHRSDA Identifier Reference Number:    ECR/4263/MH/UK/2020/RR-21
   First Posted:    November 11, 2020    
   Last Update Posted:    August 12, 2022
   Last Verified:    August 2022
   Individual Participant Data (IPD) Sharing Statement:
   Plan to Share IPD:    No
   Studies a U.S. FDA-regulated Drug Product:    Not Applicable, Reason: Nutraceutical
   Studies a U.S. FDA-regulated Device Product:    No
   Product Manufactured in and Exported from the U.S.:    No
   Type of Drug Used: Nutraceutical

   Product Tested by any Organisation: Yes (Labdoor USA Tested & Certified)

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   Keywords: Depression, Nutraceutical, CreatineMonohydrate, Depressive Symptoms, Anti Depressant. 
 

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