Trial Outcomes & Findings for Open-Label Creatine Study for Female Meth Users (NCT NCT02189915)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

8-week

Results posted on

2016-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Creatine Monohydrate Treatment This study is an open label study, where all participants received Creatine monohydrate.
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Creatine Study for Female Meth Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Creatine Monohydrate n=14 Participants Creatine monohydrate
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate Treatment n=11 Participants This study is an open label study, where all participants received Creatine monohydrate.
Depression Rating Scores Baseline	16.86 units on a scale Standard Deviation 3.40
Depression Rating Scores After 8 weeks of treatment	7.36 units on a scale Standard Deviation 4.59

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate Treatment n=10 Participants This study is an open label study, where all participants received Creatine monohydrate.
Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy Baseline	0.223 Phosphocreatine levels (unitless) Standard Deviation 0.013
Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy Post-treatment	0.233 Phosphocreatine levels (unitless) Standard Deviation 0.009

Adverse Events

Creatine Monohydrate Treatment

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Creatine Monohydrate Treatment n=14 participants at risk This study is an open label study, where all participants received Creatine monohydrate.
General disorders Flu like symptoms	92.9% 13/14
Gastrointestinal disorders Indigestion, Nausea	42.9% 6/14
Nervous system disorders Numbness, tingling	7.1% 1/14
General disorders Swelling in hands	28.6% 4/14
Eye disorders Blurry vision	7.1% 1/14

Additional Information

Perry Renshaw, MD, PhD, MBA

The Brain Institute of the University of Utah

Phone: 801-587-1216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place