Trial Outcomes & Findings for Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram (NCT NCT00851006)

Last Updated: 2017-05-12

Results Overview

The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Creatine Treatment Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.	Healthy Control Group Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Creatine Treatment n=7 Participants Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13-18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
Age, Continuous Age	15.6 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: This outcome measure was not assessed in the "Healthy Controls". Only subjects in treatment group were evaluated with CDRS-R and received scores.

Outcome measures

Outcome measures
Measure	Open Label Creatine Treatment n=7 Participants The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.	Healthy Control Group 6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.] Baseline	69 Units on a scale Standard Deviation 9.69	—
Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.] After 8 week Creatine treatment	30.6 Units on a scale Standard Deviation 8.5	—

SECONDARY outcome

Timeframe: 8 weeks

Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.

Outcome measures

Outcome measures
Measure	Open Label Creatine Treatment n=7 Participants The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.	Healthy Control Group n=6 Participants 6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite Baseline	0.1513 ratio of PCr and total phosphorus Standard Deviation 0.0137	0.1556 ratio of PCr and total phosphorus Standard Deviation 0.0086
31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite After 8 weeks	0.1610 ratio of PCr and total phosphorus Standard Deviation 0.0165	0.1558 ratio of PCr and total phosphorus Standard Deviation 0.0154

Adverse Events

Open Label Creatine Treatment

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Healthy Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Creatine Treatment n=7 participants at risk There were no serious adverse events were experienced in this study.	Healthy Control Group n=6 participants at risk Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
Nervous system disorders Intermittent tremors	14.3% 1/7 • Number of events 1	0.00% 0/6
Psychiatric disorders Suicidal ideation	14.3% 1/7 • Number of events 1	0.00% 0/6
Respiratory, thoracic and mediastinal disorders Respiratory issues	71.4% 5/7 • Number of events 5	0.00% 0/6
Gastrointestinal disorders Gastrointestinal issues	71.4% 5/7 • Number of events 6	0.00% 0/6
General disorders Headache, flu-like symptoms, epistaxis, allergies	42.9% 3/7 • Number of events 9	0.00% 0/6
Musculoskeletal and connective tissue disorders Muscle spasm	14.3% 1/7 • Number of events 1	0.00% 0/6

Additional Information

Douglas Kondo, M.D.

University of Utah

Phone: 801-587-1549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place