NCT01608399 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hagen R, Hjemdal O, Solem S, Kennair LE, Nordahl HM, Fisher P, Wells A
Metacognitive Therapy for Depression in Adults: A Waiting List Randomized Controlled Trial with Six Months Follow-Up. Front Psychol. 2017 Jan 24;8:31. doi: 10.3389/fpsyg.2017.00031. e
Hjemdal O, Solem S, Hagen R, Kennair LEO, Nordahl HM, Wells A
A Randomized Controlled Trial of Metacognitive Therapy for Depression: Analysis of 1-Year Follow-Up. Front Psychol. 2019 Aug 8;10:1842. doi: 10.3389/fpsyg.2019.01842. eCollection 2019.

A Randomized Controlled Trial of the Effectiveness of Metacognitive Therapy (MCT) in the Treatment of Patients With Major Depressive Disorder (MDD)

Clinical trial NCT01608399 - References